Gastric Outlet Obstruction
Conditions
Keywords
endoscopy, esophagogastroduodenoscopy, gastric outlet obstruction, gastro-jejunostomy, gastric malignancy, duodenal stent, Malignant Gastric Outlet Obstruction
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.
Interventions
DEVICECook Magnetic Anastomosis Device (MAD) with Stent
Gastro-jejunal anastomosis
Sponsors
MED Institute, Incorporated
Cook Endoscopy
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, Italy, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Magnetic Anastomosis Device (MAD) With Stent Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death due to progressive malignancy | 2 |
| Overall Study | Stent not placed | 1 |
| Overall Study | Unsuccessful magnet placements | 3 |
Baseline characteristics
| Characteristic | Magnetic Anastomosis Device (MAD) With Stent |
|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 11 |
| Current Treatments Brachytherapy | 0 participants |
| Current Treatments Chemotherapy | 4 participants |
| Current Treatments No treatment - Palliative care only | 10 participants |
| Current Treatments Other | 1 participants |
| Current Treatments Patients with no current treatments | 3 participants |
| Current Treatments Radiotherapy | 0 participants |
| Karnofsky Score | 72.2 Units on a scale STANDARD_DEVIATION 9.4 |
| Presenting Condition Cholangio cancer | 3 participants |
| Presenting Condition Gastric cancer | 1 participants |
| Presenting Condition Other | 2 participants |
| Presenting Condition Pancreatic cancer | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 12 |
| serious Total, serious adverse events | 10 / 12 |
Outcome results
Primary
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.
Time frame: Approximately 8-10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magnetic Anastomosis Device (MAD) With Stent | 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 | 12 participants |
Post Hoc
Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD)
Endoscopy was performed to determine whether an anastomosis (hole) was successfully created.
Time frame: Approximately 8-10 days
Population: Patients who underwent a second endoscopy after successful magnet placement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magnetic Anastomosis Device (MAD) With Stent | Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD) | 13 participants |