Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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
Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.
Approximately 8-10 days
Yes
Paul Fockens, MD, PhD
Principal Investigator
Amsterdam Academic Medical Center
Netherlands: Medical Ethics Review Committee (METC)
06-014
NCT00487552
January 2008
April 2011
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