EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Last updated: March 14, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vomiting

Treatment

Lumen-apposing metal stent

Self-expandable metal stent

Clinical Study ID

NCT03259763
IRB00128878
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with malignant, symptomatic gastric outlet obstruction due to anunresectable malignant lesion

  • Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)

  • Age 18-80 years

Exclusion

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 inbed)

  • 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 orproximal 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 strictureand/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 ofthe endoscopist)

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: Lumen-apposing metal stent
Phase:
Study Start date:
October 26, 2020
Estimated Completion Date:
March 14, 2026

Study 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.

Connect with a study center

  • The Research Institute of McGill University Health Centre

    Montréal, Quebec
    Canada

    Site Not Available

  • Ecuadorian Institute of Digestive Diseases (IECED)

    Guayaquil,
    Ecuador

    Site Not Available

  • Limoges University Hospital

    Limoges,
    France

    Site Not Available

  • Hospital Prive des Peupliers

    Paris,
    France

    Site Not Available

  • Asian Institute of Gastroenterology

    Hyderabad,
    India

    Site Not Available

  • Emek Medical Center

    Afula, 1834111
    Israel

    Site Not Available

  • Hospital Universitario Rio Hortega

    Valladolid, 47012
    Spain

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • The Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Brigham & Women's Hospital - Harvard

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Columbia University

    New York, New York 10027
    United States

    Active - Recruiting

  • Cuimc/Nyph

    New York, New York 10027
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Wake Forest Baptist University

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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