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

Phase 1
18 Years
Not Enrolling
Gastric Outlet Obstruction

Thank you

Trial Information

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.

Inclusion Criteria:

- Patients with unresectable malignancy with, or at risk of developing gastric outlet
obstruction with GOOSS ≤ 2

- Karnofsky Performance Score ≥ 60

Exclusion Criteria:

- Patient is unable to understand and execute informed consent

- Age below 18 years

- Patients with any prior gastrointestinal surgery that significantly alters
gastrojejunal anatomy

- Implanted cardiac pacemaker, defibrillator or ventricular assist device

- Requirement for chronic anticoagulation, or with uncorrectable coagulopathy

- Patients receiving chronic steroids or other drugs that may impair wound healing or
formation of an intact anastomosis

- Simultaneously participating in another investigational drug or device

- Patients with suspicion of, or documented multiple small bowel strictures

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Approximately 8-10 days

Safety Issue:


Principal Investigator

Paul Fockens, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Amsterdam Academic Medical Center


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

January 2008

Completion Date:

April 2011

Related Keywords:

  • Gastric Outlet Obstruction
  • endoscopy
  • esophagogastroduodenoscopy
  • gastric outlet obstruction
  • gastro-jejunostomy
  • gastric malignancy
  • duodenal stent
  • Malignant Gastric Outlet Obstruction
  • Gastric Outlet Obstruction
  • Pyloric Stenosis