Gastric Outlet ObstructionNCT03259763
EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
A study testing Lumen-apposing metal stent and Self-expandable metal stent in people with Gastric Outlet Obstruction, run by Johns Hopkins University at 9 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- Lumen-apposing metal stent and Self-expandable metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 26 Oct 2020to 15 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
United States3 sites
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Yale University
New Haven, Connecticut, 06520
Wake Forest Baptist University
Winston-Salem, North Carolina, 27157
Canada1 site
The Research Institute of McGill University Health Centre
Montreal, Quebec
About this study
Official title: EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
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).
Read the detailed description
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.
- Conditions
- Gastric Outlet Obstruction
- Being tested
- Lumen-apposing metal stent, Self-expandable metal stent
- Keywords
- Gastroenterostomy, Gastric Outlet Obstruction, Cancer, Endosonography
- Medical subject headings
- Gastric Outlet Obstruction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumen-apposing metal stentDevice
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 stentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided gastroenterostomy (EUS-GE) | Active comparator | 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. Receives: Device: Lumen-apposing metal stent |
| Enteral Stenting (ES) | Active comparator | 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. Receives: Device: Self-expandable metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Gastric Outlet Obstruction Recurrence
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.
Measured: 12 months
Secondary outcomes (9)
Technical Success Rate
Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
Measured: Day of procedure
Participants With Improved Clinical Success Rate
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.
Measured: 1 week
Length of Procedure
Duration of the procedure (minutes)
Measured: Day of procedure
Participants With Adverse Events
Participants with Adverse events based on ASGE Lexicon
Measured: 12 months
Post-procedure Length of Hospital Stay
Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge.
Measured: 1 week
Reintervention Rate for Recurrent Gastric Outlet Obstruction
Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction
Measured: 12 months
Quality of Life SF-36 Questionnaire Scoring
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.
Measured: 3 months
Overall Survival Rate
Percentage of participants surviving at 12 months after randomization, regardless of cause of death.
Measured: 1 year
Time in Days to Recurrent Gastric Outlet Obstruction
Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start26 Oct 2020
- Primary completion14 Jun 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gastric Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Mouen A. Khashab, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259763
- Sponsor's protocol ID
- IRB00128878
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2017
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 14760669Johnsson 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.
PubMed 15457364Maetani 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.
PubMed 16261429Khashab 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.
PubMed 23299137Khashab 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.
PubMed 26215646Itoi 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.
PubMed 28032663Chen 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.
PubMed 27834024Cotton 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.
PubMed 20189503Adler 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.
PubMed 11808972