Quality of LifeCERECNCT05802459
Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life (CEREC)
An observational study of Quality of Life and Dysphagia, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The goal of this prospective population-based cohort study is to assess: The evolution of the functional status of patients undergoing complex esophageal reconstruction Its impact on quality of life, depending on the type of conduit performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Dysphagia
- What is being tested?
- EORTC QLQ-C30, EORTC QLQ-OG25 and GIQLI
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2022to Sep 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population of this study is made up of patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. All patients who are candidates for complete replacement of the esophagus through reconstruction are presented to the Committee of the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB). After the multidisciplinary assessment, the most appropriate type of surgery for each patient is proposed and the patient receives the information during a scheduled appointment, at this moment the patient is asked to participate in the CEREC-2022 study.
Who may be able to join
- Adult patients (≥ 18 years of age) and of both gender.
- Candidates for complete esophageal reconstruction with cervical anastomosis, regardless of the etiology of the esophagectomy.
- Decision to indicate a coloplasty (+/- supercharged) or jejunoplasty (free, pedunculated +/- supercharged) as surgical technique after evaluation by the UREC Committee.
- Acceptance to participate in the study and comply with the program of procedures (schedule of visits).
- Signing of the informed consent.
Who cannot join
- Patients who withdraw their informed consent at any time during the course of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Uversitari de Bellvitge
Barcelona, 08907
Mònica Miró, +34 932 60 75 00, mmiro@bellvitgehospital.cat
Rodrigo Hermoza, +34 932 60 75 00, rhermoza@bellvitgehospital.cat
About this study
Official title: Prospective Evaluation of the Functional Status of Jejunoplasty and Coloplasty in Patients Undergoing Complex Esophageal Reconstruction and Its Impact on Quality of Life (CEREC)
The goal of this prospective population-based cohort study is to assess:
- The evolution of the functional status of patients undergoing complex esophageal reconstruction
- Its impact on quality of life, depending on the type of conduit performed.
Participants
- Will be asked to complete different quality of life questionnaires during every follow-up visit
- Will undergo additional tests to assess functionality
Read the detailed description
-General Justification: In recent years, esophageal reconstruction has been a great surgical challenge for the multidisciplinary teams in charge of carrying out this complex technique, associated with high morbidity and a high impact on the quality of life and functional status of patients.
One of the most important aspects of this surgery is the type of conduit used to restore digestive transit. Classically, gastroplasty has been the technique of choice due to its lower morbidity and mortality and less surgical complexity. On the other hand, in those patients in whom the stomach is not available, a coloplasty or a jejunoplasty is chosen, both of which can be associated with supercharged techniques to improve and ensure good vascular flow.
Currently, there is controversy about which type of conduit to use in the absence of a viable stomach. Since the introduction of microvascular or supercharged techniques, the postoperative results of jejunal grafts are comparable to coloplasty and even gastroplasty according to some authors.
The present study is an initiative of the Complex Esophageal Reconstruction Unit (UREC) of Bellvitge University Hospital (HUB), which aims to compare the different types of conduit used in complex esophageal reconstruction, assessing, in the short and long term, the postoperative functional status and its impact on quality of life through validated test-type tools, as well as carrying out complementary tests that allow evaluating aspects such as swallowing and dysphagia, among others.
- Hypothesis Considering the results of quality of life and functionality in the short and long term, jejunoplasty (free, pedunculated ± supercharged) could be the second technique of choice to perform in the absence of gastric conduit in complex esophageal reconstruction.
- Primary objective:
- To determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
- To describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
- Study design CEREC-2022 is a prospective population-based cohort study that aims to assess the evolution of the functional status of patients undergoing complex esophageal reconstruction and its impact on quality of life, depending on the type of conduit performed.
- Study population The target population of this study is made up of patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. All patients who are candidates for complete replacement of the esophagus through reconstruction are presented to the Committee of the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB). After the multidisciplinary assessment, the most appropriate type of surgery for each patient is proposed and the patient receives the information during a scheduled appointment, at this moment the patient is asked to participate in the CEREC-2022 study.
- Main Outcome
- Quality of life related to the swallowing function based on the conduit: it will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30), European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25), Gastrointestinal quality of life index (GIQLI) and Swallowing quality of life questionnaire (SWAL QoL)
- Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
- Secondary outcome Incidence of dysphagia evaluated by Videofluoroscopy (VDF), Incidence of stenosis of the conduit in the Upper Digestive Endoscopy (UDE), Number (percentage) of dilatations of the conduit, Number (percentage) of patients with esophagitis according to the Los Angeles classification, Nutritional status, Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group, Number of hospitalizations.
- As this is an observational study of a low-prevalent surgical indication, it is expected to include all patients scheduled for surgery from September 2022 to September 2025.
- The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
- Conditions
- Quality of Life, Dysphagia
- Being tested
- EORTC QLQ-C30, EORTC QLQ-OG25, GIQLI, SWAL QoL, Videofluoroscopy
- Keywords
- Esophageal reconstruction, Quality of life, Coloplasty, Jejunoplasty, Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-C30Other
central generic questionnaire associated with different disease specific modules
EORTC QLQ-OG25Other
module to assess the quality of life in patients with esophagogastric disease.
GIQLIOther
Gastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale.
SWAL QoLOther
Swallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia.
VideofluoroscopyProcedure or surgery
It consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing complex esophageal reconstruction | All the patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. Receives: Other: EORTC QLQ-C30; Other: EORTC QLQ-OG25; Other: GIQLI; Other: SWAL QoL; Procedure: Videofluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire.
This study aims to determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged) using the following questionnaires:
- European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30): All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
- European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25): All of the scales and single-item measures range in score from 0 to 100. A high score for all the scales and single-items represents a high level of symptomatology or problems.
- Gastrointestinal quality of life index (GIQLI): scale range from 0-144
- Swallowing quality of life questionnaire (SWAL QoL): scale range from 0-100
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
This study aims to describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Secondary outcomes (13)
Incidence of dysphagia
Incidence of dysphagia evaluated by Videofluoroscopic (VDF) using the following scales:
- Videofluoroscopic dysphagia scale (VDS)
- Dysphagia outcome and severity scale(DOSS)
- Penetration-aspiration scale(PAS)
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Incidence of stenosis of the conduit
Incidence of stenosis of the conduit in the Upper Digestive Endoscopy (UDE) that requires some therapeutic maneuver (dilatation), which is carried out during the follow-up visits: one year, two and three years.
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of dilatations of the conduit
Number (percentage) of dilatations of the conduit, per patient, carried out during the UDE within the follow-up visits: one year, two and three years.
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of patients with esophagitis
Number (percentage) of patients with esophagitis according to the Los Angeles classification evidenced in any of the UDE performed during the follow-up visits: one year, two and three years.
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of patients with chronic diarrhea
Number (percentage) of patients with chronic diarrhea during follow-up
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Body Mass Index
Weight and height will be combined to report Body Mass Index (BMI kg/m2) as a measure for indicating nutritional status
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Muscle strength measured by Handgrip strength (HGS) dynamometer
Handgrip strength expressed in Kg and assessed using the reference values for age and sex
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Serum albumin value
Measure of albumin/prealbumin in blood tests for assessment of nutritional status. Normal value: 34 - 54 g/L
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Mean 'time of need for enteral nutrition and oral nutrition supplements'
Mean 'time of need for enteral nutrition and oral nutrition supplements' during the post-surgical follow-up period.
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Volume of enteral nutrition required
Volume of enteral nutrition required during the post-surgical follow-up period.
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number of hospitalizations
Number of hospitalizations, for any reason, during the post-surgical follow-up period.
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG)
Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG) (20), highlighting anastomotic dehiscence, surgical site infection, bleeding, need for reintervention, ischaemia of the graft (up to 90 ±3 days after surgery). Number (percentage) of complications according to the Clavien-Dindo classification (21) and Comprehensive Complication Index.
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Mortality
Number (percentage) of deaths related to esophageal reconstruction (Up to 90 ±3 days after surgery).
Measured: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start15 Dec 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mònica Miró Martín, Hospital Universitari de Bellvitge
- Investigators
- Leandre Farran, Study director, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802459
- Sponsor's protocol ID
- CEREC-2022
- Acronym
- CEREC
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bothereau H, Munoz-Bongrand N, Lambert B, Montemagno S, Cattan P, Sarfati E. Esophageal reconstruction after caustic injury: is there still a place for right coloplasty? Am J Surg. 2007 Jun;193(6):660-4. doi: 10.1016/j.amjsurg.2006.08.074.
PubMed 17512272Farran-Teixido L, Miro-Martin M, Biondo S, Conde-Mourino R, Bettonica-Larranaga C, Aranda Danso H, Sans-Segarra M, Rafecas-Renau A. [Second time esophageal reconstruction surgery: coloplasty and gastroplasty]. Cir Esp. 2008 May;83(5):242-6. doi: 10.1016/s0009-739x(08)70561-x. Spanish.
PubMed 18448026Irino T, Tsekrekos A, Coppola A, Scandavini CM, Shetye A, Lundell L, Rouvelas I. Long-term functional outcomes after replacement of the esophagus with gastric, colonic, or jejunal conduits: a systematic literature review. Dis Esophagus. 2017 Dec 1;30(12):1-11. doi: 10.1093/dote/dox083.
PubMed 28881882Jacobs M, Macefield RC, Elbers RG, Sitnikova K, Korfage IJ, Smets EM, Henselmans I, van Berge Henegouwen MI, de Haes JC, Blazeby JM, Sprangers MA. Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery. Qual Life Res. 2014 May;23(4):1097-115. doi: 10.1007/s11136-013-0545-z. Epub 2013 Oct 16.
PubMed 24129668Miro M, Farran L, Estremiana F, Miquel J, Escalante E, Aranda H, Bettonica C, Galan M. Does gastric conditioning decrease the incidence of cervical oesophagogastric anastomotic leakage? Cir Esp (Engl Ed). 2018 Feb;96(2):102-108. doi: 10.1016/j.ciresp.2017.11.012. Epub 2018 Feb 17. English, Spanish.
PubMed 29459004Lamas S, Azuara D, de Oca J, Sans M, Farran L, Alba E, Escalante E, Rafecas A. Time course of necrosis/apoptosis and neovascularization during experimental gastric conditioning. Dis Esophagus. 2008;21(4):370-6. doi: 10.1111/j.1442-2050.2007.00772.x.
PubMed 18477261Farran Teixidor L, Vinals Vinals JM, Miro Martin M, Higueras Sune C, Bettonica Larranaga C, Aranda Danso H, Lopez Ojeda A, Rafecas Renau A. [Supercharged ileocoloplasty: an option for complex oesophageal reconstructions]. Cir Esp. 2011 Feb;89(2):87-93. doi: 10.1016/j.ciresp.2010.10.009. Epub 2011 Feb 1. Spanish.
PubMed 21277572Ochsner A, Owens N. Anterothoracic Oesophagoplasty for Impermeable Stricture of the Oesophagus. Ann Surg. 1934 Dec;100(6):1055-91. doi: 10.1097/00000658-193412000-00002. No abstract available.
PubMed 17856421Jiang S, Guo C, Zou B, Xie J, Xiong Z, Kuang Y, Tang J. Comparison of outcomes of pedicled jejunal and colonic conduit for esophageal reconstruction. BMC Surg. 2020 Jul 16;20(1):156. doi: 10.1186/s12893-020-00810-y.
PubMed 32677925Luan A, Hunter CL, Crowe CS, Lee GK. Comparison of Outcomes of Total Esophageal Reconstruction With Supercharged Jejunal Flap, Colonic Interposition, and Gastric Pull-up. Ann Plast Surg. 2018 May;80(5S Suppl 5):S274-S278. doi: 10.1097/SAP.0000000000001471.
PubMed 29634501Blackmon SH, Correa AM, Skoracki R, Chevray PM, Kim MP, Mehran RJ, Rice DC, Roth JA, Swisher SG, Vaporciyan AA, Yu P, Walsh GL, Hofstetter WL. Supercharged pedicled jejunal interposition for esophageal replacement: a 10-year experience. Ann Thorac Surg. 2012 Oct;94(4):1104-11; discussion 1111-3. doi: 10.1016/j.athoracsur.2012.05.123. Epub 2012 Aug 29.
PubMed 22939245Yasuda T, Shiozaki H. Esophageal reconstruction using a pedicled jejunum with microvascular augmentation. Ann Thorac Cardiovasc Surg. 2011;17(2):103-9. doi: 10.5761/atcs.ra.10.01648.
PubMed 21597405Yang YS, Shang QX, Yuan Y, Wu XY, Hu WP, Chen LQ. Comparison of Long-term Quality of Life in Patients with Esophageal Cancer after Ivor-Lewis, Mckeown, or Sweet Esophagectomy. J Gastrointest Surg. 2019 Feb;23(2):225-231. doi: 10.1007/s11605-018-3999-z. Epub 2018 Oct 8.
PubMed 30298418Stephens EH, Gaur P, Hotze KO, Correa AM, Kim MP, Blackmon SH. Super-Charged Pedicled Jejunal Interposition Performance Compares Favorably With a Gastric Conduit After Esophagectomy. Ann Thorac Surg. 2015 Aug;100(2):407-13. doi: 10.1016/j.athoracsur.2015.03.040. Epub 2015 Jun 20.
PubMed 26101096Mahajan NN, Lee MK, Yost KJ, Pierson KE, Viehman JK, Allen MS, Cassivi SD, Nichols FC, Reisenauer JS, Shen KR, Wigle DA, Blackmon SH. Preliminary Normative Standards of the Mayo Clinic Esophagectomy CONDUIT Tool. Mayo Clin Proc Innov Qual Outcomes. 2019 Nov 22;3(4):429-437. doi: 10.1016/j.mayocpiqo.2019.07.008. eCollection 2019 Dec.
PubMed 31993561
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Functional Status of Jejunoplasty and Coloplasty in Patients Undergoing Complex Esophageal Reconstruction and Its Impact on Quality of Life (CEREC)
- ClinicalTrials.gov ID
- NCT05802459
- Acronym / sponsor ID
- CEREC / CEREC-2022
- Conditions
- Quality of Life, Dysphagia
- Keywords
- Esophageal reconstruction, Quality of life, Coloplasty, Jejunoplasty, Dysphagia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective population-based cohort study is to assess:
- The evolution of the functional status of patients undergoing complex esophageal reconstruction
- Its impact on quality of life, depending on the type of conduit performed.
Participants
- Will be asked to complete different quality of life questionnaires during every follow-up visit
- Will undergo additional tests to assess functionality
Detailed description
-General Justification: In recent years, esophageal reconstruction has been a great surgical challenge for the multidisciplinary teams in charge of carrying out this complex technique, associated with high morbidity and a high impact on the quality of life and functional status of patients.
One of the most important aspects of this surgery is the type of conduit used to restore digestive transit. Classically, gastroplasty has been the technique of choice due to its lower morbidity and mortality and less surgical complexity. On the other hand, in those patients in whom the stomach is not available, a coloplasty or a jejunoplasty is chosen, both of which can be associated with supercharged techniques to improve and ensure good vascular flow.
Currently, there is controversy about which type of conduit to use in the absence of a viable stomach. Since the introduction of microvascular or supercharged techniques, the postoperative results of jejunal grafts are comparable to coloplasty and even gastroplasty according to some authors.
The present study is an initiative of the Complex Esophageal Reconstruction Unit (UREC) of Bellvitge University Hospital (HUB), which aims to compare the different types of conduit used in complex esophageal reconstruction, assessing, in the short and long term, the postoperative functional status and its impact on quality of life through validated test-type tools, as well as carrying out complementary tests that allow evaluating aspects such as swallowing and dysphagia, among others.
- Hypothesis Considering the results of quality of life and functionality in the short and long term, jejunoplasty (free, pedunculated ± supercharged) could be the second technique of choice to perform in the absence of gastric conduit in complex esophageal reconstruction.
- Primary objective:
- To determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
- To describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
- Study design CEREC-2022 is a prospective population-based cohort study that aims to assess the evolution of the functional status of patients undergoing complex esophageal reconstruction and its impact on quality of life, depending on the type of conduit performed.
- Study population The target population of this study is made up of patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. All patients who are candidates for complete replacement of the esophagus through reconstruction are presented to the Committee of the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB). After the multidisciplinary assessment, the most appropriate type of surgery for each patient is proposed and the patient receives the information during a scheduled appointment, at this moment the patient is asked to participate in the CEREC-2022 study.
- Main Outcome
- Quality of life related to the swallowing function based on the conduit: it will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30), European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25), Gastrointestinal quality of life index (GIQLI) and Swallowing quality of life questionnaire (SWAL QoL)
- Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
- Secondary outcome Incidence of dysphagia evaluated by Videofluoroscopy (VDF), Incidence of stenosis of the conduit in the Upper Digestive Endoscopy (UDE), Number (percentage) of dilatations of the conduit, Number (percentage) of patients with esophagitis according to the Los Angeles classification, Nutritional status, Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group, Number of hospitalizations.
- As this is an observational study of a low-prevalent surgical indication, it is expected to include all patients scheduled for surgery from September 2022 to September 2025.
- The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing complex esophageal reconstruction | – | Other: EORTC QLQ-C30, Other: EORTC QLQ-OG25, Other: GIQLI, Other: SWAL QoL, Procedure: VideofluoroscopyAll the patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of this study is made up of patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. All patients who are candidates for complete replacement of the esophagus through reconstruction are presented to the Committee of the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB). After the multidisciplinary assessment, the most appropriate type of surgery for each patient is proposed and the patient receives the information during a scheduled appointment, at this moment the patient is asked to participate in the CEREC-2022 study.
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years of age) and of both gender.
- Candidates for complete esophageal reconstruction with cervical anastomosis, regardless of the etiology of the esophagectomy.
- Decision to indicate a coloplasty (+/- supercharged) or jejunoplasty (free, pedunculated +/- supercharged) as surgical technique after evaluation by the UREC Committee.
- Acceptance to participate in the study and comply with the program of procedures (schedule of visits).
- Signing of the informed consent.
Key exclusion criteria (1 listed)
- Patients who withdraw their informed consent at any time during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ-C30central generic questionnaire associated with different disease specific modules | Other | Patients undergoing complex esophageal reconstruction |
| EORTC QLQ-OG25module to assess the quality of life in patients with esophagogastric disease. | Other | Patients undergoing complex esophageal reconstruction |
| GIQLIGastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale. | Other | Patients undergoing complex esophageal reconstruction |
| SWAL QoLSwallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia. | Other | Patients undergoing complex esophageal reconstruction |
| VideofluoroscopyIt consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia. | Procedure or surgery | Patients undergoing complex esophageal reconstruction |
Primary outcome
Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire.
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
This study aims to determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged) using the following questionnaires: * European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30): All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. * European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25): All of the scales and single-item measures range in score from 0 to 100. A high score for all the scales and single-items represents a high level of symptomatology or problems. * Gastrointestinal quality of life index (GIQLI): scale range from 0-144 * Swallowing quality of life questionnaire (SWAL QoL): scale range from 0-100
Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
This study aims to describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
13 secondary outcomes
Incidence of dysphagia
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Incidence of stenosis of the conduit
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of dilatations of the conduit
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of patients with esophagitis
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of patients with chronic diarrhea
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Body Mass Index
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Muscle strength measured by Handgrip strength (HGS) dynamometer
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Serum albumin value
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Mean 'time of need for enteral nutrition and oral nutrition supplements'
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Volume of enteral nutrition required
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number of hospitalizations
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG)
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Mortality
Time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 17512272Bothereau H, Munoz-Bongrand N, Lambert B, Montemagno S, Cattan P, Sarfati E. Esophageal reconstruction after caustic injury: is there still a place for right coloplasty? Am J Surg. 2007 Jun;193(6):660-4. doi: 10.1016/j.amjsurg.2006.08.074.
- Background: PubMed 18448026Farran-Teixido L, Miro-Martin M, Biondo S, Conde-Mourino R, Bettonica-Larranaga C, Aranda Danso H, Sans-Segarra M, Rafecas-Renau A. [Second time esophageal reconstruction surgery: coloplasty and gastroplasty]. Cir Esp. 2008 May;83(5):242-6. doi: 10.1016/s0009-739x(08)70561-x. Spanish.
- Background: PubMed 28881882Irino T, Tsekrekos A, Coppola A, Scandavini CM, Shetye A, Lundell L, Rouvelas I. Long-term functional outcomes after replacement of the esophagus with gastric, colonic, or jejunal conduits: a systematic literature review. Dis Esophagus. 2017 Dec 1;30(12):1-11. doi: 10.1093/dote/dox083.
- Background: PubMed 24129668Jacobs M, Macefield RC, Elbers RG, Sitnikova K, Korfage IJ, Smets EM, Henselmans I, van Berge Henegouwen MI, de Haes JC, Blazeby JM, Sprangers MA. Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery. Qual Life Res. 2014 May;23(4):1097-115. doi: 10.1007/s11136-013-0545-z. Epub 2013 Oct 16.
- Background: PubMed 29459004Miro M, Farran L, Estremiana F, Miquel J, Escalante E, Aranda H, Bettonica C, Galan M. Does gastric conditioning decrease the incidence of cervical oesophagogastric anastomotic leakage? Cir Esp (Engl Ed). 2018 Feb;96(2):102-108. doi: 10.1016/j.ciresp.2017.11.012. Epub 2018 Feb 17. English, Spanish.
- Background: PubMed 18477261Lamas S, Azuara D, de Oca J, Sans M, Farran L, Alba E, Escalante E, Rafecas A. Time course of necrosis/apoptosis and neovascularization during experimental gastric conditioning. Dis Esophagus. 2008;21(4):370-6. doi: 10.1111/j.1442-2050.2007.00772.x.
- Background: PubMed 21277572Farran Teixidor L, Vinals Vinals JM, Miro Martin M, Higueras Sune C, Bettonica Larranaga C, Aranda Danso H, Lopez Ojeda A, Rafecas Renau A. [Supercharged ileocoloplasty: an option for complex oesophageal reconstructions]. Cir Esp. 2011 Feb;89(2):87-93. doi: 10.1016/j.ciresp.2010.10.009. Epub 2011 Feb 1. Spanish.
- Background: PubMed 17856421Ochsner A, Owens N. Anterothoracic Oesophagoplasty for Impermeable Stricture of the Oesophagus. Ann Surg. 1934 Dec;100(6):1055-91. doi: 10.1097/00000658-193412000-00002. No abstract available.
- Background: PubMed 32677925Jiang S, Guo C, Zou B, Xie J, Xiong Z, Kuang Y, Tang J. Comparison of outcomes of pedicled jejunal and colonic conduit for esophageal reconstruction. BMC Surg. 2020 Jul 16;20(1):156. doi: 10.1186/s12893-020-00810-y.
- Background: PubMed 29634501Luan A, Hunter CL, Crowe CS, Lee GK. Comparison of Outcomes of Total Esophageal Reconstruction With Supercharged Jejunal Flap, Colonic Interposition, and Gastric Pull-up. Ann Plast Surg. 2018 May;80(5S Suppl 5):S274-S278. doi: 10.1097/SAP.0000000000001471.
- Background: PubMed 22939245Blackmon SH, Correa AM, Skoracki R, Chevray PM, Kim MP, Mehran RJ, Rice DC, Roth JA, Swisher SG, Vaporciyan AA, Yu P, Walsh GL, Hofstetter WL. Supercharged pedicled jejunal interposition for esophageal replacement: a 10-year experience. Ann Thorac Surg. 2012 Oct;94(4):1104-11; discussion 1111-3. doi: 10.1016/j.athoracsur.2012.05.123. Epub 2012 Aug 29.
- Background: PubMed 21597405Yasuda T, Shiozaki H. Esophageal reconstruction using a pedicled jejunum with microvascular augmentation. Ann Thorac Cardiovasc Surg. 2011;17(2):103-9. doi: 10.5761/atcs.ra.10.01648.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leandre Farran study director
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Dysphagia, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Miró (+34932607500, mmiro@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire. (time frame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802459, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.