Clinical trial NCT01491698: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: stomach
surgery
Total Gastrectomy
Roux-En-Y Pouch Reconstruction
Conventional Roux-En-Y Reconstruction
Quality of Life
11-170
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: McMaster University
First posted: 2011-12-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: feasibility
timeFrame: 2 years
Secondary outcomes:
measure: change in HRQOL ( Health-Related Quality of Life)
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniel Coit, MD
role: PRINCIPAL_INVESTIGATOR
References: