Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Outlet Obstruction

Intervention / Treatment
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* Device: Cook Magnetic Anastomosis Device (MAD) with Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>palliative treatment of gastric outlet obstruction | Device: Cook Magnetic Anastomosis Device (MAD) with Stent<br>* Gastro-jejunal anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, esophagogastroduodenoscopy, gastric outlet obstruction, gastro-jejunostomy, gastric malignancy, duodenal stent, Malignant Gastric Outlet Obstruction