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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01491698

Collaborator

Weill Medical College of Cornell University (Other), McMaster University (Other)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Procedure: Roux-en-Y pouch reconstruction (RYP) Procedure: conventional Roux-en-Y reconstruction (RYC)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pts undergoing Roux-en-Y pouch reconstruction (RYP) This is a pilot randomized controlled trial comparing changes in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma.	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). Other Names: Patients will be seen in follow-up at intervals congruent with routine post-operative care: post-operative (approximately 1 month), 3 months, 6 months, 12 months, and 24 months following surgery (+- one month at each time interval to allow flexibility in scheduling). At each of these visits patients will complete the HRQOL questionnaires, which require approximately 30 minutes total.
Active Comparator: pts undergoing conventional Roux-en-Y reconstruction (RYC) This is a pilot randomized controlled trial comparing change in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma.	Procedure: 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). Other Names: Patients will be seen in follow-up at intervals congruent with routine post-operative care: post-operative (approximately 1 month), 3 months, 6 months, 12 months, and 24 months following surgery (+- one month at each time interval to allow flexibility in scheduling). At each of these visits patients will complete the HRQOL questionnaires, which require approximately 30 minutes total.

Arm

Intervention/Treatment

Experimental: pts undergoing Roux-en-Y pouch reconstruction (RYP)

This is a pilot randomized controlled trial comparing changes in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma.

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).

Other Names:

Patients will be seen in follow-up at intervals congruent with routine post-operative

care: post-operative (approximately 1 month), 3 months, 6 months, 12 months,

and 24 months following surgery (+- one month at each time interval to allow

flexibility in scheduling). At each of these visits patients will complete the

HRQOL questionnaires, which require approximately 30 minutes total.

Active Comparator: pts undergoing conventional Roux-en-Y reconstruction (RYC)

This is a pilot randomized controlled trial comparing change in health-related quality of life (HRQOL) in patients undergoing Roux-en-Y pouch reconstruction (RYP) with patients undergoing conventional Roux-en-Y reconstruction (RYC) following total gastrectomy for adenocarcinoma.

Procedure: conventional Roux-en-Y reconstruction (RYC)

Other Names:

Patients will be seen in follow-up at intervals congruent with routine post-operative care:

post-operative (approximately 1 month), 3 months, 6 months, 12 months, and

24 months following surgery (+- one month at each time interval to allow flexibility in scheduling). At each of these visits patients will complete the

HRQOL questionnaires, which require approximately 30 minutes total.

Outcome Measures

Primary Outcome Measures

feasibility [2 years]
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.

Secondary Outcome Measures

change in HRQOL ( Health-Related Quality of Life) [2 years]
from preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)