Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
1 other identifier
interventional
74
1 country
1
Brief Summary
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2022
CompletedStudy Start
First participant enrolled
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 12, 2025
March 1, 2025
2.7 years
September 16, 2022
June 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
Proportion of patients unable to tolerate a solid diet at time of hospital discharge (defined as gastric outlet obstruction scoring system score \<2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
6 months
Secondary Outcomes (16)
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
6 months
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
6 months
Rate of technical success
24 hours
Procedure duration
24 hours
Time to diet advancement
1 month
- +11 more secondary outcomes
Study Arms (2)
EUS-guided gastrojejunostomy
ACTIVE COMPARATOREUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent
Surgical gastrojejunostomy
ACTIVE COMPARATORA surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.
Interventions
AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
- Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
- Amenable to treatment by both EUS-guided and surgical gastrojejunostomy
You may not qualify if:
- Age \< 18 years
- Intrauterine pregnancy
- Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
- Unable to obtain consent for the procedure from either the patient or LAR
- Altered anatomy due to prior gastroduodenal surgery
- Presence of other adhesions or synchronous obstructive lesions in the small bowel
- Prior treatment for gastric outlet obstruction
- Presence of large volume malignant ascites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orlando Health, Inc.lead
- West Virginia Universitycollaborator
- Rush Universitycollaborator
- Asian Institute of Gastroenterology, Indiacollaborator
- Medanta, The Medicity, Indiacollaborator
- University of Hamburg-Eppendorfcollaborator
Study Sites (1)
Orlando Health
Orlando, Florida, 32806, United States
Related Publications (1)
Bang JY, Puri R, Lakhtakia S, Thakkar S, Waxman I, Siddiqui I, Arnold K, Chaudhary A, Mehta S, Singh A, Venkat Rao G, Basha J, Gupta R, Modak S, Singh S, Boone B, Dautel P, Dixon MEB, Kim HM, Sutton B, Arnoletti JP, Rosch T, Varadarajulu S. Endoscopic or surgical gastroenterostomy for malignant gastric outlet obstruction: a randomised trial. Gut. 2025 Dec 5;75(1):24-32. doi: 10.1136/gutjnl-2025-336339.
PMID: 40998416DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Young Bang, MD MPH
Orlando Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 21, 2022
Study Start
September 16, 2022
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
June 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share