EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

NCT ID: NCT03259763

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2026-03-14

Brief 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. 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EUS-guided gastroenterostomy (EUS-GE)

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.

Group Type: ACTIVE_COMPARATOR

Lumen-apposing metal stent

Intervention Type: 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.

Enteral Stenting (ES)

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.

Group Type: ACTIVE_COMPARATOR

Self-expandable metal stent

Intervention Type: 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.

Interventions

Lumen-apposing metal stent

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.

Intervention Type: DEVICE

Self-expandable metal stent

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mouen A. Khashab, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Yale University

New Haven, Connecticut, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Wake Forest Baptist University

Winston-Salem, North Carolina, United States

The Research Institute of McGill University Health Centre

Montreal, Quebec, Canada

Ecuadorian Institute of Digestive Diseases (IECED)

Guayaquil, , Ecuador

Hospital Prive des Peupliers

Paris, , France

Asian Institute of Gastroenterology

Hyderabad, , India

Emek Medical Center

Afula, , Israel

Hospital Universitario Rio Hortega

Valladolid, , Spain

Countries

United States; Canada; Ecuador; France; India; Israel; Spain

References

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20189503 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11808972 (View on PubMed)

Other Identifiers

IRB00128878

Identifier Type: -

Identifier Source: org_study_id