Clinical trial · Interventional
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
NCT05548114CI-TRIAL-00090955active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Outlet Obstruction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided gastrojejunostomy | Procedure | — | UNRESOLVED |
| Surgical gastrojejunostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-guided gastrojejunostomy
- description
- EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent
- interventionNames
- Procedure: EUS-guided gastrojejunostomy
- type
- ACTIVE_COMPARATOR
- label
- Surgical gastrojejunostomy
- description
- A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.
- interventionNames
- Procedure: Surgical gastrojejunostomy
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy 3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only) 4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy Exclusion Criteria: 1. Age \< 18 years 2. Intrauterine pregnancy 3. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy 4. Unable to obtain consent for the procedure from either the patient or LAR 5. Altered anatomy due to prior gastroduodenal surgery 6. Presence of other adhesions or synchronous obstructive lesions in the small bowel 7. Prior treatment for gastric outlet obstruction 8. Presence of large volume malignant ascites
References
Publications (1)
- DERIVEDBang 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 40998416