Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Health-Related Quality of Life in Patients Undergoing Total Gastrectomy for Adenocarcinoma

Gastric Cancer Clinical Trial

Official title:

A Pilot Randomized Controlled Trial Examining the Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Health-Related Quality of Life in Patients Undergoing Total Gastrectomy for Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491698
• Other study ID #: 11-070
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2011
• Last updated: August 14, 2013
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is being done to learn more about how different surgery procedures bring back the eating pathway after removing the stomach in patients with stomach cancer. If the surgeon has decided that some, or all, of the patient's stomach must be removed the surgeon must create a new way to allow food to travel from the mouth to the intestines. Some patients develop problems because they are missing their stomach, such as lack of hunger, bloating, cramping, and heartburn.

The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if a change in surgery can help reduce these symptoms.

The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestine is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines lower down.

The change in surgery involves creating a pouch from a part of the intestines to replace the stomach.

This study will compare the effects, good and/or bad, of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes you feel better overall.

This type of surgery has been used by some surgeons for many years and is known to be safe, but it is not known if it reduces symptoms or improves nutrition compared with the usual surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient 18 years of age or older

• Pathologically confirmed gastric adenocarcinoma at MSKCC (biopsy may be performed at other institutions but slides must be confirmed at MSKCC, as is routine care at our institution)

• No evidence of metastases(a)

• Total gastrectomy performed(b)

• Pouch reconstruction is technically feasible(c)

• Patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. If metastatic disease is identified at the time of operation, the patient will not be randomized.

• Patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a total gastrectomy at the time of operation. If a total gastrectomy is not performed, the patient will not be randomized.

• Patients will be excluded if, at the time of surgery, the surgeon feels that creation of a pouch is not technically feasible. This may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion.

Exclusion Criteria:

• Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)

• Not able to complete HRQOL instruments on their own (non-English speaking or physical status)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer

Intervention

Procedure:
• Roux-en-Y pouch reconstruction (RYP)
Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).
• conventional Roux-en-Y reconstruction (RYC)
Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	McMaster University, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility	of recruiting patients with gastric adenocarcinoma to this randomized controlled trial (RCT). We will assess this based on the number of patients who are randomized during the pilot study.	2 years	No
Secondary	change in HRQOL ( Health-Related Quality of Life)	from preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.	2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center