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NCT01491698 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Gastric Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01491698 is a Phase 3 study of Gastric Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 12 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01491698, a Phase 3 study of Gastric Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Roux-en-Y pouch reconstruction (RYP)
- PROCEDURE conventional Roux-en-Y reconstruction (RYC)
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01491698
The ClinicalTrials.gov registry entry for NCT01491698 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastric Cancer appearing as the primary indexed condition, and to 2 interventions - of which Roux-en-Y pouch reconstruction (RYP) is the first listed.
NCT01491698 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01491698 about?
NCT01491698 is a clinical study titled "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 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 fo...
What is the current status of trial NCT01491698?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2011-12. Estimated completion is 2013-08.
What conditions does trial NCT01491698 study?
This clinical trial studies the following conditions: Gastric Cancer.
What interventions are being tested in trial NCT01491698?
The interventions under investigation include: Roux-en-Y pouch reconstruction (RYP) (PROCEDURE), conventional Roux-en-Y reconstruction (RYC) (PROCEDURE).
Who is sponsoring clinical trial NCT01491698?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01491698 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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