Clinical Trial: Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction

Brief Summary: The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.

Detailed Summary: Surgical treatments for malignant gastric outlet obstructions carry substantial risks and are associated with postoperative morbidity. External compression from advancing tumor or tissue growth through the stent can cause stenosis or re-obstruction. In these patients, the creation of a patent fistula that allows gastric emptying may significantly improve palliation. Minimally invasive techniques that carry no greater risks than enteral stenting may provide a viable palliative treatment. The primary objectives are safety, and successful creation of a gastro-jejunal anastomosis. Secondary objectives are successful resumption or improvement in the ability to tolerate PO feeding, rate of stent migration, and duration of stent and anastomosis patency.
Sponsor: Cook

Current Primary Outcome: Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent [ Time Frame: Approximately 8-10 days ]

Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.


Original Primary Outcome: Success rate and safety associated with the creation of a gastro-jejunal anastomosis using the Cook Magnetic Anastomosis Device with trans-anastomotic deployment of the Yo-Yo gastro-jejunal stent

Current Secondary Outcome:

Original Secondary Outcome:

  • Improvement in ability to tolerate oral feeding
  • Rate of stent migration
  • Duration of patency of stent and gastro-jejunal anastomosis


Information By: Cook

Dates:
Date Received: June 15, 2007
Date Started: January 2008
Date Completion:
Last Updated: December 29, 2015
Last Verified: June 2012