Feasibility, Safety and QoL After Merendino Procedure

Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection Clinical Trial

— MER  

Official title:

The Merendino Procedure for Benign or Early Malignant Lesions of the Distal Esophagus/Gastroesophageal Junction is Feasible, Safe and Provides Good QoL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855333
• Other study ID #: KLiestal
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: August 3, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Kantonsspital Liestal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• alive

• MER or CON procedure

• informed consent

• CON patients were matched according to diagnosis, Age and ASA score

Exclusion Criteria:

• withdrawal of informed consent

• legal incapacity

• limitations in mental state or medical condition precluding questioning (only QoL data)

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection

Intervention

Other:
• EORTC and QLQ-C30 / QLQ-OES24 questionnaire
EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baselland, Liestal	Liestal	Basel-Land

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Liestal

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Götzky K, Jähne 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. German. — View Citation

Hölscher AH, Vallböhmer 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. Review. — View Citation

Mangano 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. — View Citation

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. — View Citation

Zapletal 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (QoL)	EORTC QLQ-C30 and QLQ-OES24 questionnaire (global health status item, functional and symptom scale items)	up to 10 years after surgery	No
Secondary	Intraoperative complications	Blood loss (ml), requirement for blood transfusion (units), operation time (min)	up to 1 day after surgery	No
Secondary	Postoperative complications	Morbidity (re-intervention rate, re-operation rate), in-hospital mortality	up to 100 days after surgery	No