EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions.

Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.

• Lumen-apposing metal stent (Device): 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.
• Self-expandable metal stent (Device): 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.

Primary outcomes

• Percentage of Participants With Gastric Outlet Obstruction Recurrence [12 months]: Defined as percentage of participants with recurrence of nausea, vomiting, and inability to tolerate PO intake up to 12 months after the procedure confirmed either endoscopically and/or radiographically.

Secondary outcomes

• Technical Success Rate [Day of procedure]: Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
• Participants With Improved Clinical Success Rate [1 week]: Participants with improvement of at least 1 point in the gastric outlet obstruction score range 0-3 (0 as no oral intake to 3 as complete diet) within 7 days after stent insertion. Higher score better.
• Length of Procedure [Day of procedure]: Duration of the procedure (minutes)
• Participants With Adverse Events [12 months]: Participants with Adverse events based on ASGE Lexicon
• Post-procedure Length of Hospital Stay [1 week]: Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge.
• Reintervention Rate for Recurrent Gastric Outlet Obstruction [12 months]: Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction
• Quality of Life SF-36 Questionnaire Scoring [3 months]: The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.
• Overall Survival Rate [1 year]: Percentage of participants surviving at 12 months after randomization, regardless of cause of death.
• Time in Days to Recurrent Gastric Outlet Obstruction [12 months]: Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction

Sex: All, ages: 18 Years to 80 Years

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)

Participant flow

Outcome results

• Percentage of Participants With Gastric Outlet Obstruction Recurrence (Primary), Number, Percentage of Participants: EUS-guided Gastroenterostomy (EUS-GE) 0 (0 to 0); Enteral Stenting (ES) 15.4 (5.3 to 25.4)
• Technical Success Rate (Secondary), Count of participants, Participants: EUS-guided Gastroenterostomy (EUS-GE) 56; Enteral Stenting (ES) 52
• Participants With Improved Clinical Success Rate (Secondary), Count of participants, Participants: EUS-guided Gastroenterostomy (EUS-GE) 50; Enteral Stenting (ES) 42
• Length of Procedure (Secondary), Mean, Minutes: EUS-guided Gastroenterostomy (EUS-GE) 24.3 +/- 12.5; Enteral Stenting (ES) 15.8 +/- 8.1
• Participants With Adverse Events (Secondary), Count of participants, Participants: EUS-guided Gastroenterostomy (EUS-GE) 4; Enteral Stenting (ES) 4
• Post-procedure Length of Hospital Stay (Secondary), Mean, days: EUS-guided Gastroenterostomy (EUS-GE) 0.7 +/- 0.6; Enteral Stenting (ES) 0.9 +/- 1.5
• Reintervention Rate for Recurrent Gastric Outlet Obstruction (Secondary), Number, Percentage of Participants: EUS-guided Gastroenterostomy (EUS-GE) 0 (0 to 0); Enteral Stenting (ES) 15.4 (5.4 to 25.4)
• Quality of Life SF-36 Questionnaire Scoring (Secondary), Mean, Baseline adjusted mean score: EUS-guided Gastroenterostomy (EUS-GE) 38.7 (29.5 to 48.0); Enteral Stenting (ES) 44.1 (34.9 to 53.3)
• Overall Survival Rate (Secondary), Number, Percentage of Participants: EUS-guided Gastroenterostomy (EUS-GE) 15.6 (8.2 to 29.9); Enteral Stenting (ES) 13.5 (6.8 to 26.8)
• Time in Days to Recurrent Gastric Outlet Obstruction (Secondary), Median, days: EUS-guided Gastroenterostomy (EUS-GE) ; Enteral Stenting (ES) 149 (7 to 252)

Adverse events

Time frame: Up to 12 months

Serious adverse events by term

Other adverse events by term

• Mittal 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
• Johnsson 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
• Maetani 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
• Khashab 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
• Khashab 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
• Itoi 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
• Chen 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. PMID 27834024
• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available. PMID 20189503
• Adler DG, Baron TH. Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol. 2002 Jan;97(1):72-8. doi: 10.1111/j.1572-0241.2002.05423.x. PMID 11808972

• Study Protocol and Statistical Analysis Plan (PDF, 2025-11-17)

• Mouen A. Khashab, MD, Principal investigator, Johns Hopkins University