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

This study has been completed.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
McMaster University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01491698
First received: December 9, 2011
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Gastric Cancer
Procedure: Roux-en-Y pouch reconstruction (RYP)
Procedure: conventional Roux-en-Y reconstruction (RYC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    from preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.


Enrollment: 12
Study Start Date: December 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491698

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
McMaster University
Investigators
Principal Investigator: Daniel Coit, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01491698     History of Changes
Other Study ID Numbers: 11-070
Study First Received: December 9, 2011
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stomach
surgery
Total Gastrectomy
Roux-En-Y Pouch Reconstruction
Conventional Roux-En-Y Reconstruction
Quality of Life
11-170

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 29, 2014