Esophageal CancerCIR·ROBNCT04652180
Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
A study testing Esophagectomy in people with Esophageal Cancer and Esophageal Carcinoma, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
This is a randomized controlled trial designed to compare robot-assisted thoracic approach with open transthoracic esophagectomy (Ivor Lewis technique) as a surgical treatment for resectable esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Carcinoma, Postoperative Complications
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 6 Nov 2020to 30 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years.
- Histologically proven adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma or carcinoma of the gastro-esophageal junction (GEJ) Siewert I or II.
- Surgical resectable (T1-4a, N0-3, M0).
- Childbearing potential women (period between menarche and menopause), pregnancy negative test is mandatory.
- Written informed consent.
Who cannot join
- Stage IV or GEJ Siewert III esophageal cancer.
- Contraindication of transthoracic esophagectomy in two fields.
- Pre- or concomitant cancer or conditions which interferes with the study (e.g. prior thoracic surgery or trauma. Rationale: these patients may undergo open resection).
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 Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907.
Natàlia Cornellà, Surgeon, +34645976556, nataliacornellagcirurgia@gmail.com
About this study
Official title: Clinical Trial Of Safety Of Robot-assisted Thoracic Approach Verus Open Transthoracic Esophagectomy in Esophageal Cancer.
This is a randomized controlled trial designed to compare robot-assisted thoracic approach with open transthoracic esophagectomy (Ivor Lewis technique) as a surgical treatment for resectable esophageal cancer.
If our hypothesis is proved correct, robot-assisted thoracic approach will result in a lower percentage of respiratory and overall postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
Read the detailed description
Rationale: Esophageal cancer represents the fifth most common tumor of cancers of the digestive system in Spain, between the ten most common cancers and the sixth leading cause of cancer death in the world. Among the standard modalities for treatment with curative intention, surgery is available, in combination with neoadjuvant (pre-surgery) and/or adjuvant (post-surgery) chemotherapy and radiation therapy. Esophageal surgery is crucial to improve overall survival in patients with esophageal cancer.
Surgical treatment is based on esophageal resection and reconstruction of digestive transit, as well as a correct lymphadenectomy. One of the techniques used is Ivor Lewis transthoracic esophagectomy. Classically, thoracic approach has been done by open approach (thoracotomy), with minimally invasive (laparoscopy) abdominal approach, a reality in our centre and in most European centres.
Postoperative comorbidity, specially respiratory complications, occur approximately in half of patients with esophagectomy with thoracotomy (open approach). Although current clinical trials have reported advantages over minimally invasive esophagectomy (MI), at the time, most esophageal surgery is performed by open approach. More studies are needed to clarify the role of minimally invasive esophagectomy in esophageal cancer, so as to provide evidence about the comorbidity and effectiveness of surgical robot-assisted technique.
If our hypothesis is proved correct, robot-assisted thoracic approach will result in a lower percentage of respiratory and overall postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
Objective: Evaluate the benefits, risks and cost-efficiency of Robot-assisted thoracic approach as a better approach to open transthoracic Ivor Lewis esophagectomy as treatment for esophageal cancer.
Study design: This is an investigator-initiated and investigator-driven monocentre randomized controlled parallel-group, phase IV, superiority trial.
Study populations: Patients (age ≥ 18) with histologically proven surgical resectable (cT1-4a, N0-3, M0) adenocarcinoma, squamous cell carcinoma, undifferentiated esophageal carcinoma or carcinomas of the esophagogastric junction (EGJ) (Siewert I or II) candidate to Ivor Lewis Esophagectomy.
Intervention:108 patients will be randomly allocated to either A) Robot-assisted thoracic approach or B) Open transthoracic esophagectomy, in Ivor Lewis technique. In both groups the abdominal approach will be performed by laparoscopy (minimally invasive).
Patients will receive the following interventions:
Group A. Robot-assisted thoracic approach in Ivor Lewis esophagectomy. Group B. Open transthoracic approach (thoracotomy) in Ivor Lewis esophagectomy.
Both surgical techniques are used in our usual clinical practice of the General and Digestive Surgery Department of the Bellvitge University Hospital (HUB).
Main study parameters/endpoints: Primary outcome is the percentage of respiratory and overall complications as stated by the modified Clavien-Dindo classification (MCDC).
Secondary outcomes are individual components of the primary endpoint (major and minor complications), (in hospital) mortality, R0 resections, oncologic outcomes, postoperative recovery, cost-effectiveness and quality of life.
Follow-up:84±3 days after hospital discharge.
NOTE: The project consists of a clinical trial and an extension study to assess the free-survival of 3 and 5 years from surgery.
- Being tested
- Esophagectomy
- Medical subject headings
- Esophageal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Also called Robot-assisted minimally invasive esophagectomy, Robot-assisted thoracic approach in Ivor Lewis esophagectomy
In this monocentre randomized controlled trial, we compare robot-assisted thoracic approach with conventional open transthoracic Ivor Lewis esophagectomy.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted thoracic approach in Ivor Lewis esophagectomy | Experimental | Robot-assisted thoracic approach in Ivor Lewis esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy. Receives: Procedure: Esophagectomy |
| Open transthoracic approach in Ivor Lewis esophagectomy | Active comparator | Traditional open transthoracic esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy. Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory postoperative complications.
The primary outcome of this study is the percentage of respiratory complications as stated by the modified Clavien-Dindo classification of surgical complications (MCDC).
by means of AME chest approach by robot and thoracotomy (classic surgery).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.
Secondary outcomes (8)
Postoperative complications.
Estimate the percentage of overall complications as stated by the modified Clavien-Dindo classification of surgical complications (MCDC) by means of Robot-assisted thoracic approach and thoracotomy (classic surgery).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.
Individual components of the primary endpoint (major and minor complications).
Major complications (MCDC Grade 2-4): anastomotic leakage (clinical or radiologic diagnosis), anastomotic stenosis, chylothorax (chylous leakage, presence of chylous in chest tubes or indication start medium chain triglycerides containing tube feeding), gastric tube necrosis (proven by gastroscopy), pulmonary embolus, pneumothorax, deep vein thrombosis, myocardial infarction, vocal cord palsy or paralysis.
Minor complications (MCDC Grade 1): wound infections, pleural effusions, delayed gastric emptying.
All these postoperative complications will be properly and separately recorded in the electronic collection database.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge
Postoperative mortality (during hospital stay up to 84+/-3 days after discharge).
(In hospital) mortality and mortality within 14+/-2 days and 84+/-3 days after hospital discharge will be reported. The cause of death will be noted.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.
Operation related events.
Operation time is defined as time from incision until closure (minutes) for both the thoracic and the abdominal phase of the procedure. For the robotic approach, set up time will be recorded separately. Unexpected events and complications occuring during operation will be recorded (e.g. massive hemorrhage, perforation of other organs). Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has tp be explained (absolute numbers/percentage).
Measured: Day of surgery, up to 24 hours after surgery.
Postoperative recovery.
Pain: type and dose of used analgesics will be noted during the hospital admission period and noted during the follow-up period. Unit of measure: Visual Analog Score for pain.
Length of intensive care unit (ICU) (days). Length of hospital stay (days).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
R0 resections (%).
The pathological analysis will be finished within 2-3 weeks after surgery.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and 14+/- days after discharge.
Oncologic outcomes.
Overall survival within the first 84+/-3 days. NOTE: 2, 3 and 5 year disease free and overall survival will be reported in the study of extension .
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84+/-3 days after discharge.
Postoperative quality of life.
Postoperative quality of life will be assessed through Physicians Global Assessment to measure quality of life:
Questionnaires EORTC QLQ-C30 and EQ-5D will be required from 14+/-2 up to 84+/-3 days after hospital discharge.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84+/-3 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start6 Nov 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentre randomized controlled parallel-group, phase IV, superiority trial. The main purpose is to demonstrate the superiority of robot-assisted thoracic approach over thoracotomy (conventional surgery) in decreasing respiratory and overall complications in Ivor Lewis-type esophagectomy.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Carla Bettonica, PhD, Hospital Universitari de Bellvitge
- Investigators
- Leandre Farran, PhD Surgeon, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652180
- Sponsor's protocol ID
- HUB-CIR-ROB-2020-01
- Acronym
- CIR·ROB
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Publications
Stahl M, Mariette C, Haustermans K, Cervantes A, Arnold D; ESMO Guidelines Working Group. Oesophageal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi51-6. doi: 10.1093/annonc/mdt342. No abstract available.
PubMed 24078662Inderhees S, Dubecz A. [Hybrid minimally invasive esophagectomy for esophageal cancer-MIRO trial]. Chirurg. 2019 Aug;90(8):677. doi: 10.1007/s00104-019-0983-4. No abstract available. German.
PubMed 31127335van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.
PubMed 30308612Straatman J, van der Wielen N, Cuesta MA, Daams F, Roig Garcia J, Bonavina L, Rosman C, van Berge Henegouwen MI, Gisbertz SS, van der Peet DL. Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial. Ann Surg. 2017 Aug;266(2):232-236. doi: 10.1097/SLA.0000000000002171.
PubMed 28187044Avery KN, Metcalfe C, Berrisford R, Barham CP, Donovan JL, Elliott J, Falk SJ, Goldin R, Hanna G, Hollowood AA, Krysztopik R, Noble S, Sanders G, Streets CG, Titcomb DR, Wheatley T, Blazeby JM. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer--the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial. Trials. 2014 Jun 2;15:200. doi: 10.1186/1745-6215-15-200.
PubMed 24888266Brierley RC, Gaunt D, Metcalfe C, Blazeby JM, Blencowe NS, Jepson M, Berrisford RG, Avery KNL, Hollingworth W, Rice CT, Moure-Fernandez A, Wong N, Nicklin J, Skilton A, Boddy A, Byrne JP, Underwood T, Vohra R, Catton JA, Pursnani K, Melhado R, Alkhaffaf B, Krysztopik R, Lamb P, Culliford L, Rogers C, Howes B, Chalmers K, Cousins S, Elliott J, Donovan J, Heys R, Wickens RA, Wilkerson P, Hollowood A, Streets C, Titcomb D, Humphreys ML, Wheatley T, Sanders G, Ariyarathenam A, Kelly J, Noble F, Couper G, Skipworth RJE, Deans C, Ubhi S, Williams R, Bowrey D, Exon D, Turner P, Daya Shetty V, Chaparala R, Akhtar K, Farooq N, Parsons SL, Welch NT, Houlihan RJ, Smith J, Schranz R, Rea N, Cooke J, Williams A, Hindmarsh C, Maitland S, Howie L, Barham CP. Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT). BMJ Open. 2019 Nov 19;9(11):e030907. doi: 10.1136/bmjopen-2019-030907.
PubMed 31748296Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603.
PubMed 22668811Pennathur A, Luketich JD, Landreneau RJ, Ward J, Christie NA, Gibson MK, Schuchert M, Cooper K, Land SR, Belani CP. Long-term results of a phase II trial of neoadjuvant chemotherapy followed by esophagectomy for locally advanced esophageal neoplasm. Ann Thorac Surg. 2008 Jun;85(6):1930-6; discussion 1936-7. doi: 10.1016/j.athoracsur.2008.01.097.
PubMed 18498797
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Of Safety Of Robot-assisted Thoracic Approach Verus Open Transthoracic Esophagectomy in Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT04652180
- Acronym / sponsor ID
- CIR·ROB / HUB-CIR-ROB-2020-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Dec 2020 (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.
This is a randomized controlled trial designed to compare robot-assisted thoracic approach with open transthoracic esophagectomy (Ivor Lewis technique) as a surgical treatment for resectable esophageal cancer.
If our hypothesis is proved correct, robot-assisted thoracic approach will result in a lower percentage of respiratory and overall postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
Detailed description
Rationale: Esophageal cancer represents the fifth most common tumor of cancers of the digestive system in Spain, between the ten most common cancers and the sixth leading cause of cancer death in the world. Among the standard modalities for treatment with curative intention, surgery is available, in combination with neoadjuvant (pre-surgery) and/or adjuvant (post-surgery) chemotherapy and radiation therapy. Esophageal surgery is crucial to improve overall survival in patients with esophageal cancer.
Surgical treatment is based on esophageal resection and reconstruction of digestive transit, as well as a correct lymphadenectomy. One of the techniques used is Ivor Lewis transthoracic esophagectomy. Classically, thoracic approach has been done by open approach (thoracotomy), with minimally invasive (laparoscopy) abdominal approach, a reality in our centre and in most European centres.
Postoperative comorbidity, specially respiratory complications, occur approximately in half of patients with esophagectomy with thoracotomy (open approach). Although current clinical trials have reported advantages over minimally invasive esophagectomy (MI), at the time, most esophageal surgery is performed by open approach. More studies are needed to clarify the role of minimally invasive esophagectomy in esophageal cancer, so as to provide evidence about the comorbidity and effectiveness of surgical robot-assisted technique.
If our hypothesis is proved correct, robot-assisted thoracic approach will result in a lower percentage of respiratory and overall postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
Objective: Evaluate the benefits, risks and cost-efficiency of Robot-assisted thoracic approach as a better approach to open transthoracic Ivor Lewis esophagectomy as treatment for esophageal cancer.
Study design: This is an investigator-initiated and investigator-driven monocentre randomized controlled parallel-group, phase IV, superiority trial.
Study populations: Patients (age ≥ 18) with histologically proven surgical resectable (cT1-4a, N0-3, M0) adenocarcinoma, squamous cell carcinoma, undifferentiated esophageal carcinoma or carcinomas of the esophagogastric junction (EGJ) (Siewert I or II) candidate to Ivor Lewis Esophagectomy.
Intervention:108 patients will be randomly allocated to either A) Robot-assisted thoracic approach or B) Open transthoracic esophagectomy, in Ivor Lewis technique. In both groups the abdominal approach will be performed by laparoscopy (minimally invasive).
Patients will receive the following interventions:
Group A. Robot-assisted thoracic approach in Ivor Lewis esophagectomy. Group B. Open transthoracic approach (thoracotomy) in Ivor Lewis esophagectomy.
Both surgical techniques are used in our usual clinical practice of the General and Digestive Surgery Department of the Bellvitge University Hospital (HUB).
Main study parameters/endpoints: Primary outcome is the percentage of respiratory and overall complications as stated by the modified Clavien-Dindo classification (MCDC).
Secondary outcomes are individual components of the primary endpoint (major and minor complications), (in hospital) mortality, R0 resections, oncologic outcomes, postoperative recovery, cost-effectiveness and quality of life.
Follow-up:84±3 days after hospital discharge.
NOTE: The project consists of a clinical trial and an extension study to assess the free-survival of 3 and 5 years from surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentre randomized controlled parallel-group, phase IV, superiority trial. The main purpose is to demonstrate the superiority of robot-assisted thoracic approach over thoracotomy (conventional surgery) in decreasing respiratory and overall complications in Ivor Lewis-type esophagectomy.
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted thoracic approach in Ivor Lewis esophagectomy | Experimental | Procedure: EsophagectomyRobot-assisted thoracic approach in Ivor Lewis esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy. |
| Open transthoracic approach in Ivor Lewis esophagectomy | Active comparator | Procedure: EsophagectomyTraditional open transthoracic esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Histologically proven adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma or carcinoma of the gastro-esophageal junction (GEJ) Siewert I or II.
- Surgical resectable (T1-4a, N0-3, M0).
- Childbearing potential women (period between menarche and menopause), pregnancy negative test is mandatory.
- Written informed consent.
Key exclusion criteria (3 listed)
- Stage IV or GEJ Siewert III esophageal cancer.
- Contraindication of transthoracic esophagectomy in two fields.
- Pre- or concomitant cancer or conditions which interferes with the study (e.g. prior thoracic surgery or trauma. Rationale: these patients may undergo open resection).
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 |
|---|---|---|
| EsophagectomyAlso: Robot-assisted minimally invasive esophagectomy, Robot-assisted thoracic approach in Ivor Lewis esophagectomyIn this monocentre randomized controlled trial, we compare robot-assisted thoracic approach with conventional open transthoracic Ivor Lewis esophagectomy. | Procedure or surgery | Open transthoracic approach in Ivor Lewis esophagectomy, Robot-assisted thoracic approach in Ivor Lewis esophagectomy |
Primary outcome
Respiratory postoperative complications.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.
The primary outcome of this study is the percentage of respiratory complications as stated by the modified Clavien-Dindo classification of surgical complications (MCDC). by means of AME chest approach by robot and thoracotomy (classic surgery).
8 secondary outcomes
Postoperative complications.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.
Individual components of the primary endpoint (major and minor complications).
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge
Postoperative mortality (during hospital stay up to 84+/-3 days after discharge).
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.
Operation related events.
Time frame: Day of surgery, up to 24 hours after surgery.
Postoperative recovery.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
R0 resections (%).
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and 14+/- days after discharge.
Oncologic outcomes.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84+/-3 days after discharge.
Postoperative quality of life.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84+/-3 days after discharge.
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 1 Mar 2023.
- Results publication: PubMed 24078662Stahl M, Mariette C, Haustermans K, Cervantes A, Arnold D; ESMO Guidelines Working Group. Oesophageal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi51-6. doi: 10.1093/annonc/mdt342. No abstract available.
- Results publication: PubMed 31127335Inderhees S, Dubecz A. [Hybrid minimally invasive esophagectomy for esophageal cancer-MIRO trial]. Chirurg. 2019 Aug;90(8):677. doi: 10.1007/s00104-019-0983-4. No abstract available. German.
- Results publication: PubMed 30308612van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.
- Results publication: PubMed 28187044Straatman J, van der Wielen N, Cuesta MA, Daams F, Roig Garcia J, Bonavina L, Rosman C, van Berge Henegouwen MI, Gisbertz SS, van der Peet DL. Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial. Ann Surg. 2017 Aug;266(2):232-236. doi: 10.1097/SLA.0000000000002171.
- Results publication: PubMed 24888266Avery KN, Metcalfe C, Berrisford R, Barham CP, Donovan JL, Elliott J, Falk SJ, Goldin R, Hanna G, Hollowood AA, Krysztopik R, Noble S, Sanders G, Streets CG, Titcomb DR, Wheatley T, Blazeby JM. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer--the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial. Trials. 2014 Jun 2;15:200. doi: 10.1186/1745-6215-15-200.
- Results publication: PubMed 31748296Brierley RC, Gaunt D, Metcalfe C, Blazeby JM, Blencowe NS, Jepson M, Berrisford RG, Avery KNL, Hollingworth W, Rice CT, Moure-Fernandez A, Wong N, Nicklin J, Skilton A, Boddy A, Byrne JP, Underwood T, Vohra R, Catton JA, Pursnani K, Melhado R, Alkhaffaf B, Krysztopik R, Lamb P, Culliford L, Rogers C, Howes B, Chalmers K, Cousins S, Elliott J, Donovan J, Heys R, Wickens RA, Wilkerson P, Hollowood A, Streets C, Titcomb D, Humphreys ML, Wheatley T, Sanders G, Ariyarathenam A, Kelly J, Noble F, Couper G, Skipworth RJE, Deans C, Ubhi S, Williams R, Bowrey D, Exon D, Turner P, Daya Shetty V, Chaparala R, Akhtar K, Farooq N, Parsons SL, Welch NT, Houlihan RJ, Smith J, Schranz R, Rea N, Cooke J, Williams A, Hindmarsh C, Maitland S, Howie L, Barham CP. Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT). BMJ Open. 2019 Nov 19;9(11):e030907. doi: 10.1136/bmjopen-2019-030907.
- Results publication: PubMed 22668811Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603.
- Results publication: PubMed 18498797Pennathur A, Luketich JD, Landreneau RJ, Ward J, Christie NA, Gibson MK, Schuchert M, Cooper K, Land SR, Belani CP. Long-term results of a phase II trial of neoadjuvant chemotherapy followed by esophagectomy for locally advanced esophageal neoplasm. Ann Thorac Surg. 2008 Jun;85(6):1930-6; discussion 1936-7. doi: 10.1016/j.athoracsur.2008.01.097.
- Esophageal cancerLink provided by the sponsor.
- SurvivalLink provided by the sponsor.
- Cancer StagingLink provided by the sponsor.
- DiagnosisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
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, PhD Surgeon study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagectomy in people with Esophageal Cancer and Esophageal Carcinoma, 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 3 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 1 Mar 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 Natàlia Cornellà, Surgeon (+34645976556, nataliacornellagcirurgia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory postoperative complications. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.). 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 NCT04652180, which also lists 8 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 1 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.