Clinical trial NCT00487552: Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction
Official title: Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastric Outlet Obstruction
Keywords: endoscopy
esophagogastroduodenoscopy
gastric outlet obstruction
gastro-jejunostomy
gastric malignancy
duodenal stent
Malignant Gastric Outlet Obstruction
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
Collaborators: name: MED Institute, Incorporated
name: Cook Endoscopy
First posted: 2007-06-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Approximately 8-10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hospital de Erasme
city: Rome
country: Italy
facility: Instituto di Clinical Chirurgica
city: Amsterdam
country: Netherlands
facility: Amsterdam Academic Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Amsterdam Academic Medical Center
name: Paul Fockens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: