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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

feasibility

Outcome 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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Daniel Coit, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-070

NCT ID:

NCT01491698

Start Date:

December 2011

Completion Date:

December 2016

Related Keywords:

  • Gastric Cancer
  • stomach
  • surgery
  • Total Gastrectomy
  • Roux-En-Y Pouch Reconstruction
  • Conventional Roux-En-Y Reconstruction
  • Quality of Life
  • 11-170
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021