EPASS Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.
Gastric Outlet Obstruction
About this trial
This is an interventional treatment trial for Gastric Outlet Obstruction
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients ≥ 18 years old
- Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
- Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1
- Performance status ECOG ≤3
Exclusion Criteria:
- Prior metallic stent placement
- Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
- Life expectancy of less than 1 month
- History of gastric surgery
- Linitus plastic
- Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel series or abdominal computed tomography
- Coagulation disorders
- Pregnancy
- Unable to give informed consent
Sites / Locations
- Department of Surgery, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EUS-guided gastrojejunostomy
Pyloro-duodenal stent
The procedures would be performed under conscious sedation or monitored anesthesia by a therapeutic gastroscope. The endoscope would be used to reach the site of obstruction. The stricture would be cannulated with a 0.025" or 0.035" guide-wire. The double balloon occluder would then be inserted on guidewire beyond the duodenal-jejunal flexure and the two balloons of the occluder would be inflated. A segment of duodenum/jejunum would then be occluded and saline would be injected. A linear echoendoscope would then be inserted into the stomach to guide insertion of the gastrojejunostomy stent.
The uncovered DS used in this study is Wallflex (Boston, Natick, MA, USA), made of nitinol wire, with a diameter of 22mm and length of 6, 9, 12cm. This stent is a braided stent with high axial force, good flexibility and conformability.