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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

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Roux-en-Y pouch reconstruction (RYP)

conventional Roux-en-Y reconstruction (RYC)

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring stomach, surgery, Total Gastrectomy, Roux-En-Y Pouch Reconstruction, Conventional Roux-En-Y Reconstruction, Quality of Life, 11-170

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

pts undergoing conventional Roux-en-Y reconstruction (RYC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01491698

First Posted

December 9, 2011

Last Updated

August 14, 2013

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Weill Medical College of Cornell University, McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT01491698

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Weill Medical College of Cornell University, McMaster University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

stomach, surgery, Total Gastrectomy, Roux-En-Y Pouch Reconstruction, Conventional Roux-En-Y Reconstruction, Quality of Life, 11-170

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

pts undergoing conventional Roux-en-Y reconstruction (RYC)

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Roux-en-Y pouch reconstruction (RYP)

Other Intervention Name(s)

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.

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

conventional Roux-en-Y reconstruction (RYC)

Other Intervention Name(s)

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.

Intervention Description

Primary Outcome Measure Information:

Title

feasibility

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

change in HRQOL ( Health-Related Quality of Life)

Description

from preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Coit, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/

Description

Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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