Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical ResectionMERNCT02855333
Feasibility, Safety and QoL After Merendino Procedure
An observational study of Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection, run by Kantonsspital Liestal at 1 site in Switzerland.
Trial summary
The purpose of this study is to analyse retrospectively the early postoperative and functional outcome of patients (pts) after Merendino procedure for benign or early malignant lesions of the distal part of the esophagus or the gastroesophageal junction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection
- What is being tested?
- EORTC and QLQ-C30 / QLQ-OES24 questionnaire
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients who underwent Merendino procedure between 08/2004 and 02/2013 at the Kantonal Hospital of Baselland, Liestal (Switzerland) were included into the Merendino (MER) group. Considering indication for surgery, age, ASA score, and co-morbidities, patients who underwent gastrectomy during the same period were matched for control (CON) group.
Who may be able to join
- alive
- MER or CON procedure
- informed consent
- CON patients were matched according to diagnosis, Age and ASA score
Who cannot join
- withdrawal of informed consent
- legal incapacity
- limitations in mental state or medical condition precluding questioning (only QoL data)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Baselland, Liestal
Liestal, Basel-Landschaft, 4410
About this study
Official title: The Merendino Procedure for Benign or Early Malignant Lesions of the Distal Esophagus/Gastroesophageal Junction is Feasible, Safe and Provides Good QoL
The purpose of this study is to analyse retrospectively the early postoperative and functional outcome of patients (pts) after Merendino procedure for benign or early malignant lesions of the distal part of the esophagus or the gastroesophageal junction.
Read the detailed description
Between 2004 and 2013, 14 pts had transhiatal resection of median 8 (6-10) cm of distal esophagus including the gastroesophageal junction. Locoregional lymphadenectomy was performed in all patients with (suspected) early adenocarcinoma. In case of vagus nerve resection, pyloromyectomy and cholecystectomy were done. A pediculated isoperistaltic jejunal segment of 15-18 cm length was interponed between esophageal stump and remaining stomach by end-to-side anastomoses. At least one postoperative contrast examination of the anastomoses was done in all pts. Quality of life was assessed by using the EORTC QLQ-OES18 survey, recording patients' general activity and condition and specific gastrointestinal symptoms.
- Being tested
- EORTC and QLQ-C30 / QLQ-OES24 questionnaire
- Keywords
- Merendino procedure, Feasibility, Safety and QoL of the Merendino procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC and QLQ-C30 / QLQ-OES24 questionnaireOther
EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure
| Study group | Role | What they receive |
|---|---|---|
| Merendino Group (MER) | Patients who underwent merendino procedure for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire Receives: Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire | |
| Control Group (CON) | Patients who underwent alternative surgery for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire Receives: Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL)
EORTC QLQ-C30 and QLQ-OES24 questionnaire (global health status item, functional and symptom scale items)
Measured: up to 10 years after surgery
Secondary outcomes (2)
Intraoperative complications
Blood loss (ml), requirement for blood transfusion (units), operation time (min)
Measured: up to 1 day after surgery
Postoperative complications
Morbidity (re-intervention rate, re-operation rate), in-hospital mortality
Measured: up to 100 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical ResectionStudies 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
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Liestal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph A Maurer, MD, PhD, Study director, Hirslanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855333
- Sponsor's protocol ID
- KLiestal
- Acronym
- MER
- Status last verified
- Aug 2016
- First submitted
- 13 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zapletal C, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint: reply. World J Surg. 2014 Nov;38(11):3034. doi: 10.1007/s00268-014-2723-8. No abstract available.
PubMed 25189438Gotzky K, Jahne J. [Quality of life after operation for early Barrett's cancer: a prospective comparison of Ivor Lewis resection versus modified Merendino resection]. Chirurg. 2014 Sep;85(9):822. doi: 10.1007/s00104-014-2856-1. No abstract available. German.
PubMed 25123190Mangano A, Lianos GD, Rausei S, Boni L, Dionigi G. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint. World J Surg. 2014 Nov;38(11):3033. doi: 10.1007/s00268-014-2624-x. No abstract available.
PubMed 24791672Zapletal Ch, Heesen Ch, Origer J, Pauthner M, Pech O, Ell Ch, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. World J Surg. 2014 Jun;38(6):1444-52. doi: 10.1007/s00268-013-2410-1.
PubMed 24378548Holscher AH, Vallbohmer D, Gutschow C, Bollschweiler E. Reflux esophagitis, high-grade neoplasia, and early Barrett's carcinoma-what is the place of the Merendino procedure? Langenbecks Arch Surg. 2009 May;394(3):417-24. doi: 10.1007/s00423-008-0429-9. Epub 2008 Nov 7.
PubMed 18989696
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Merendino Procedure for Benign or Early Malignant Lesions of the Distal Esophagus/Gastroesophageal Junction is Feasible, Safe and Provides Good QoL
- ClinicalTrials.gov ID
- NCT02855333
- Acronym / sponsor ID
- MER / KLiestal
- Keywords
- Merendino procedure, Feasibility, Safety and QoL of the Merendino procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kantonsspital LiestalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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 purpose of this study is to analyse retrospectively the early postoperative and functional outcome of patients (pts) after Merendino procedure for benign or early malignant lesions of the distal part of the esophagus or the gastroesophageal junction.
Detailed description
Between 2004 and 2013, 14 pts had transhiatal resection of median 8 (6-10) cm of distal esophagus including the gastroesophageal junction. Locoregional lymphadenectomy was performed in all patients with (suspected) early adenocarcinoma. In case of vagus nerve resection, pyloromyectomy and cholecystectomy were done. A pediculated isoperistaltic jejunal segment of 15-18 cm length was interponed between esophageal stump and remaining stomach by end-to-side anastomoses. At least one postoperative contrast examination of the anastomoses was done in all pts. Quality of life was assessed by using the EORTC QLQ-OES18 survey, recording patients' general activity and condition and specific gastrointestinal symptoms.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Merendino Group (MER) | – | Other: EORTC and QLQ-C30 / QLQ-OES24 questionnairePatients who underwent merendino procedure for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire |
| Control Group (CON) | – | Other: EORTC and QLQ-C30 / QLQ-OES24 questionnairePatients who underwent alternative surgery for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent Merendino procedure between 08/2004 and 02/2013 at the Kantonal Hospital of Baselland, Liestal (Switzerland) were included into the Merendino (MER) group. Considering indication for surgery, age, ASA score, and co-morbidities, patients who underwent gastrectomy during the same period were matched for control (CON) group.
Key inclusion criteria (4 listed)
- alive
- MER or CON procedure
- informed consent
- CON patients were matched according to diagnosis, Age and ASA score
Key exclusion criteria (3 listed)
- withdrawal of informed consent
- legal incapacity
- limitations in mental state or medical condition precluding questioning (only QoL data)
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 and QLQ-C30 / QLQ-OES24 questionnaireEORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure | Other | Control Group (CON), Merendino Group (MER) |
Primary outcome
Quality of Life (QoL)
Time frame: up to 10 years after surgery
EORTC QLQ-C30 and QLQ-OES24 questionnaire (global health status item, functional and symptom scale items)
2 secondary outcomes
Intraoperative complications
Time frame: up to 1 day after surgery
Postoperative complications
Time frame: up to 100 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Background: PubMed 25189438Zapletal C, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint: reply. World J Surg. 2014 Nov;38(11):3034. doi: 10.1007/s00268-014-2723-8. No abstract available.
- Background: PubMed 25123190Gotzky K, Jahne J. [Quality of life after operation for early Barrett's cancer: a prospective comparison of Ivor Lewis resection versus modified Merendino resection]. Chirurg. 2014 Sep;85(9):822. doi: 10.1007/s00104-014-2856-1. No abstract available. German.
- Background: PubMed 24791672Mangano A, Lianos GD, Rausei S, Boni L, Dionigi G. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint. World J Surg. 2014 Nov;38(11):3033. doi: 10.1007/s00268-014-2624-x. No abstract available.
- Background: PubMed 24378548Zapletal Ch, Heesen Ch, Origer J, Pauthner M, Pech O, Ell Ch, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. World J Surg. 2014 Jun;38(6):1444-52. doi: 10.1007/s00268-013-2410-1.
- Background: PubMed 18989696Holscher AH, Vallbohmer D, Gutschow C, Bollschweiler E. Reflux esophagitis, high-grade neoplasia, and early Barrett's carcinoma-what is the place of the Merendino procedure? Langenbecks Arch Surg. 2009 May;394(3):417-24. doi: 10.1007/s00423-008-0429-9. Epub 2008 Nov 7.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Christoph A Maurer, MD, PhD study director
Hirslanden
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 Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection, run by Kantonsspital Liestal at 1 site in Switzerland.
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 4 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: finished, as of the sponsor's last update on 4 Aug 2016. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: up to 10 years after surgery). 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 NCT02855333, which also lists 5 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 4 Aug 2016.