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Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

NCT06567691 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-08-26

No results posted yet for this study

Summary

Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.

EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach \[4\]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Patrick Yachimski, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06567691 on ClinicalTrials.gov