Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy

NANot yet recruitingINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2026

Conditions
Gastric Outlet Obstruction
Interventions
PROCEDURE

a novel balloon-assisted EUS-GE

The patients will receive EUS-NBAGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, contrast medium is injected to determine the location and length of the stricture. A guidewire is then placed through the stricture into the jejunum, approximately 15 cm distal to the anal side of the stricture. A double-balloon device is inserted over the guidewire. The anal-side balloon is inflated with about 40 mL of air, and under fluoroscopy, the balloon is confirmed to be well inflated. A mixture of contrast medium and methylene blue in a 1:1 dilution is injected into the proximal small intestine through the water injection channel at the proximal end of the catheter. A linear echoendoscope is inserted into the mid-body of the stomach on the greater curvature side to scan the distended small intestine loop. After identifying the distended small intestine loop, a HOT-AXIOS 1.5×1.0cm LAMS is placed under direct visualization.

PROCEDURE

direct EUS-GE

"The patients will receive EUS-DGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, a guidewire and/or nasobiliary catheter is passed through the stricture into the jejunum. A mixture of contrast medium and methylene blue is injected to distend the target intestinal loop. An echoendoscope is introduced into the stomach to select the optimal puncture site.~A 19G or 22G puncture needle is used to puncture the gastric and jejunal walls. Aspiration of fluid confirms the needle tip is in the jejunum, after which the channel is dilated over the guidewire. Using the delivery system of an electrocautery-enhanced fully covered lumen-apposing metal stent (LAMS), the stent is deployed to complete the gastrojejunostomy."

All Listed Sponsors
lead

Changhai Hospital

OTHER

NCT07161856 - Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy | Biotech Hunter | Biotech Hunter