Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

NAEnrolling by invitationINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Malignant Gastric Outlet Obstruction
Interventions
PROCEDURE

EUS Gastrojejunostomy

Endoscopic Ultrasound (EUS) Gastrojejunostomy. Under live real-time EUS visualization, a solution of normal saline or water and dilute methylene blue will be infused through the nasobiliary drainage catheter to mechanically distend the small intestine and create a suitable, expanded fluid-filled target for transgastric access. Once a suitable target has been identified, a lumen apposing metal stent (LAMS) will then be deployed securely across the newly created gastroenterostomy tract. Appropriate stent placement will be confirmed.

PROCEDURE

Surgical Gastrojejunostomy

Gastrojejunostomy will be performed via an open technique using an upper midline or left sub-costal incision (at the discretion of the surgeon). An antecolic, pro-peristaltic, gastrojejunostomy will be performed using one of two standard techniques: 1) hand-sewn: 2-layer anastomosis using absorbable suture or 2) stapled: single-layer anastomosis using a surgical stapler with closed staple height ranging from 1.0 - 1.5 mm and suture closure of the common enterotomy. Feeding tube placement will be at the discretion of the operating surgeon and if performed, will be performed via a Stamm technique. Abdominal fascial closure will be performed with absorbable, monofilament, suture and skin will be closed using staples or suture at the discretion of the surgeon.

OTHER

Gastric Outlet Obstruction Scoring System (GOOSS)

A previously validated instrument for assessing tolerance of oral intake.

Trial Locations (1)

37212

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER