EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

March 12, 2024 updated by: Johns Hopkins University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lauren A Sekela, MPH
  • Phone Number: 410-502-2811
  • Email: lsekela1@jh.edu

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada
        • Recruiting
        • The Research Institute of McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Yen-I Chen
  • Ecuador
      • Guayaquil, Ecuador
        • Recruiting
        • Ecuadorian Institute of Digestive Diseases (IECED)
        • Contact:
        • Principal Investigator:
          • Carlos Robles Medranda
  • France
  • India
      • Hyderabad, India
        • Recruiting
        • Asian Institute Of Gastroenterology
        • Contact:
        • Principal Investigator:
          • Sundeep Lakhtakia
  • Spain
      • Valladolid, Spain, 47012
        • Completed
        • Hospital Universitario Río Hortega
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Not yet recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Thiruvengadam Muniraj
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • The Johns Hopkins Hospital
        • Contact:
        • Principal Investigator:
          • Mouen A Khashab, MD
    • Massachusetts
    • New York
      • New York, New York, United States, 10027
        • Recruiting
        • Columbia University
        • Contact:
        • Principal Investigator:
          • Kavel Visrodia
      • New York, New York, United States, 10016
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Todd Baron
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist University
        • Contact:
        • Principal Investigator:
          • Rishi Pawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of gastric outlet obstruction recurrence
Time Frame: 3 months
Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: Day of procedure
Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
Day of procedure
Clinical success rate
Time Frame: 1 week
The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion.
1 week
Length of procedure
Time Frame: Day of procedure
Day of procedure
Adverse events rate
Time Frame: 1 week
1 week
Post-procedure length of hospital stay
Time Frame: 1 week
1 week
Reintervention rate for recurrent gastric outlet obstruction
Time Frame: 3 months
3 months
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.
3 months
Overall survival rate
Time Frame: 1 year
1 year
Time to recurrent gastric outlet obstruction
Time Frame: 3 months
3 months
Gastric Outlet Obstruction Scoring system (GOOSS)
Time Frame: 1 year

Diet toleration will be scored based on the Gastric Outlet Obstruction Scoring System (GOOSS). The scoring ranges from 0 to 3 in the following format:

0 = no oral intake, 1 = liquids only, 2 = soft solids, 3 = low-residue or full diet
1 year
Stent Dysfunction Rate
Time Frame: 3 months
the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture
3 months
Duration of stent patency
Time Frame: 3 months
Calculated from the time of stent placement to the time of stent dysfunction
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Mouen A. Khashab, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00128878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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