Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy for Treatment of Malignant Gastric Outlet Obstruction: a Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Malignant Gastric Outlet Obstruction
• Intervention / Treatment: Procedure: EUS Gastrojejunostomy; Other: Gastric Outlet Obstruction Scoring System (GOOSS); Procedure: Surgical Gastrojejunostomy

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Able to provide informed consent
• Biopsy-proven cancer
• Cancer without surgical resection as a curative treatment option
• Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum

Exclusion Criteria:

• Age <18 years
• Pregnancy
• Unable to provide informed consent
• White Blood Count < 3,000
• Absolute Neutrophil Count < 1,500
• International normalized ratio > 1.6
• Platelet count < 100,000
• Cancer with surgical resection as a curative treatment option
• Surgically altered foregut anatomy
• Multifocal intestinal obstruction
• Abdominal ascites prohibitive of surgical candidacy
• Abdominal wall mesh prohibitive of surgical candidacy
• Child's Class B or C cirrhosis
• Gastroesophageal varices or known portal hypertension
• Body mass index >40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EUS Gastrojejunostomy; Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure	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.; Other: Gastric Outlet Obstruction Scoring System (GOOSS); A previously validated instrument for assessing tolerance of oral intake.
Active Comparator: Surgical Gastrojejunostomy; Patient will undergo Surgical Gastrojejunostomy procedure.	Other: Gastric Outlet Obstruction Scoring System (GOOSS); A previously validated instrument for assessing tolerance of oral intake.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy	A GOOSS score of 0 will be defined as intolerant of oral intake, while any GOOSS score greater than 0 will be defined as tolerant of oral intake. 0: no oral intake; oral liquids only; soft solids; low residue or full diet This will be given to subjects	1 day post-operative
Compare post procedure length of hospital stay	This outcome will be measured as the length of hospital stay (in days) from study intervention to discharge. Any accrued hospital stay from admission prior to study intervention will not be included in this assessment.	14 days post-operative

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Patrick Yachimski, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastric Outlet Obstruction; Pyloric Stenosis
• Other Study ID Numbers: 240747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No