Status:
COMPLETED
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
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Weill Medical College of Cornell University
McMaster University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01491698
Start Date
December 1 2011
End Date
August 1 2013
Last Update
August 15 2013
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065