Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction
Malignant Gastric Outlet Obstruction
About this trial
This is an interventional treatment trial for Malignant Gastric Outlet Obstruction
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients ≥ 20 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:
- Unable to give informed consent
- Prior duodenal metallic stent placement
- Severe comorbidities precluding the endoscopic procedure or operation
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EUS-guided gastroenterostomy (EUS-GE)
Laparoscopic gastroenterostomy (LGE)
All EUS-GE procedures were performed under general anesthesia with endotracheal intubation. A forward-viewing gastroscope or side-viewing duodenoscope is first inserted into the site of the obstruction and a 0.025- or 0.035-inch stiff GW is placed down-stream of the jejunum beyond the obstruction as far as possible. Then, oral enteral tube is placed where the jejunum intended for stent placement under fluoroscopic guidance. After exchanging to EUS endoscope, the target jejunum is visualized by EUS after continuously injection of mixed saline and contrast medium. Finally, the gastrojejunostomy stent is directly advanced from the gastric wall into the target jejunum by AXIOS-EC delivery system.
All LGE were performed in the operation room with patients under general anesthesia. After CO2 insufflation, 4 to 5 trocars were introduced. Next, the Treitz ligament was identified. An anterior, dorsal laterolateral, or side- to-side isoperistaltic gastroenteric anastomosis was constructed. The exact location of the gastroenteric anastomosis, with regard to the Treitz ligament, varied from 30 to 60 cm.