Clinical trial · Interventional
EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
NCT03259763CI-TRIAL-00116781completedN/AResults postedClinicalTrials.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)
Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).
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 |
|---|---|---|---|
| Lumen-apposing metal stent | Device | — | UNRESOLVED |
| Self-expandable metal stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-guided gastroenterostomy (EUS-GE)
- description
- In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
- interventionNames
- Device: Lumen-apposing metal stent
- type
- ACTIVE_COMPARATOR
- label
- Enteral Stenting (ES)
- description
- In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
- interventionNames
- Device: Self-expandable metal stent
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion * Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only) * Age 18-80 years Exclusion Criteria: * Evidence of other strictures in the gastrointestinal (GI) tract * Previous gastric, periampullary or duodenal surgery * World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed) * Unable to fill out quality of life questionnaire * Unable to sign the informed consent * Life expectancy of less than 3 months based on the endoscopist's opinion * Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal jejunum around the ligament of Treitz * Large volume ascites * Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other severe comorbidities * Pregnant or breastfeeding women * Uncorrectable coagulopathy defined by INR \> 1.5 or platelet \< 50000/µl * Complete GOO evidenced by inability to either pass a wire across the stricture and/or inability to opacify small bowel distal to the malignant stricture * Resectable or borderline resectable tumors * One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of the endoscopist)
References
Publications (9)
- BACKGROUNDMittal A, Windsor J, Woodfield J, Casey P, Lane M. Matched study of three methods for palliation of malignant pyloroduodenal obstruction. Br J Surg. 2004 Feb;91(2):205-9. doi: 10.1002/bjs.4396. PMID 14760669
- BACKGROUNDJohnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3. PMID 15457364
- BACKGROUNDMaetani I, Akatsuka S, Ikeda M, Tada T, Ukita T, Nakamura Y, Nagao J, Sakai Y. Self-expandable metallic stent placement for palliation in gastric outlet obstructions caused by gastric cancer: a comparison with surgical gastrojejunostomy. J Gastroenterol. 2005 Oct;40(10):932-7. doi: 10.1007/s00535-005-1651-7. PMID 16261429
- BACKGROUNDKhashab M, Alawad AS, Shin EJ, Kim K, Bourdel N, Singh VK, Lennon AM, Hutfless S, Sharaiha RZ, Amateau S, Okolo PI, Makary MA, Wolfgang C, Canto MI, Kalloo AN. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc. 2013 Jun;27(6):2068-75. doi: 10.1007/s00464-012-2712-7. Epub 2013 Jan 9. PMID 23299137
- BACKGROUNDKhashab MA, Kumbhari V, Grimm IS, Ngamruengphong S, Aguila G, El Zein M, Kalloo AN, Baron TH. EUS-guided gastroenterostomy: the first U.S. clinical experience (with video). Gastrointest Endosc. 2015 Nov;82(5):932-8. doi: 10.1016/j.gie.2015.06.017. Epub 2015 Jul 26. PMID 26215646
- BACKGROUNDItoi T, Baron TH, Khashab MA, Tsuchiya T, Irani S, Dhir V, Bun Teoh AY. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Dig Endosc. 2017 May;29(4):495-502. doi: 10.1111/den.12794. Epub 2017 Jan 27. PMID 28032663
- BACKGROUNDChen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, Ismail A, Ngamruengphong S, Bukhari M, Hajiyeva G, Alawad AS, Kumbhari V, Khashab MA. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc. 2017 Jul;31(7):2946-2952. doi: 10.1007/s00464-016-5311-1. Epub 2016 Nov 10.