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Completed

NCT Number: NCT03259763

EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

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).

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Key information

Conditions

Gastric Outlet Obstruction Digestive System Diseases Gastrointestinal Diseases Neoplasms Stomach Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Research Institute of McGill University Health Centre, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. Percentage of Participants With Gastric Outlet Obstruction Recurrence

    Time frame: 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

  1. Technical Success Rate

    Time frame: Day of procedure

    Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.

  2. Participants With Improved Clinical Success Rate

    Time frame: 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.

  3. Length of Procedure

    Time frame: Day of procedure

    Duration of the procedure (minutes)

  4. Participants With Adverse Events

    Time frame: 12 months

    Participants with Adverse events based on ASGE Lexicon

  5. Post-procedure Length of Hospital Stay

    Time frame: 1 week

    Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge.

  6. Reintervention Rate for Recurrent Gastric Outlet Obstruction

    Time frame: 12 months

    Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction

  7. Quality of Life SF-36 Questionnaire Scoring

    Time frame: 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.

  8. Overall Survival Rate

    Time frame: 1 year

    Percentage of participants surviving at 12 months after randomization, regardless of cause of death.

  9. Time in Days to Recurrent Gastric Outlet Obstruction

    Time frame: 12 months

    Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Aug 24, 2017
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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