Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

Not Applicable

Terminated

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 Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	Cook Magnetic Anastomosis Device (MAD) with Stent	palliative treatment of gastric outlet obstruction

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (4): Instituto di Clinical Chirurgica
🇮🇹
Rome, Italy
Hospital de Erasme
🇧🇪
Brussels, Belgium
Amsterdam Academic Medical Center
🇳🇱
Amsterdam, Netherlands
University Medical Center Utrecht
🇳🇱
Utrecht, Netherlands