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Stent

Endoscopic Stenting Techniques for Gastric Outlet Obstruction

N/A
Recruiting
Led By Mouen A. Khashab, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion
Age 18-80 years
Must not have
Large volume ascites
World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial compares two less invasive treatments for patients with a blocked stomach due to cancer. One method uses ultrasound to create a new pathway between the stomach and small intestine, while the other uses a stent to keep the blocked area open. The goal is to see which method is safer and more effective.

Who is the study for?
Adults with malignant, unresectable gastric outlet obstruction and a GOOSS score of 0 or 1 can join. They must be able to undergo sedated endoscopy and fill out questionnaires. Excluded are those with severe clotting issues, complete obstruction, critical illness preventing endoscopy, bedridden status (WHO score of 4), resectable tumors, large ascites, pregnancy/breastfeeding, other GI strictures or prior related surgeries.
What is being tested?
The trial compares two less invasive techniques for palliating gastric outlet obstruction: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) versus enteral stenting (ES). It aims to determine which method is safer and more effective in providing relief from the symptoms caused by this condition.
What are the potential side effects?
Potential side effects may include discomfort at the procedure site, bleeding due to the stent placement, infection risk post-procedure and possible complications related to sedation during endoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a cancer-caused blockage in my stomach that cannot be surgically removed.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a large amount of fluid in my abdomen.
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I spend all my time in bed due to my condition.
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I am unable to understand or sign the consent form.
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I cannot eat or drink normally due to a blockage in my stomach.
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My cancer has spread to my stomach, duodenum, or near the ligament of Treitz.
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I have had surgery on my stomach or the beginning of my small intestine.
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My tumor can possibly be removed with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of gastric outlet obstruction recurrence
Secondary study objectives
Clinical success rate
Duration of stent patency
Pyloric Stenosis
+3 more

Trial Design

2Treatment groups
Active Control
Group I: EUS-guided gastroenterostomy (EUS-GE)Active Control1 Intervention
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 II: Enteral Stenting (ES)Active Control1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) creates a new connection between the stomach and the small intestine using endoscopic ultrasonography, bypassing the obstructed area. This method allows for the restoration of normal gastric emptying and alleviates symptoms without the need for invasive surgery. Enteral Stenting (ES), on the other hand, involves placing a stent to keep the obstructed lumen open, allowing food to pass through the narrowed area. This minimally invasive approach provides immediate relief of obstruction symptoms. Both treatments are crucial for GOO patients as they offer less invasive alternatives to traditional surgical bypass, reducing recovery time and associated risks.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor
738 Previous Clinical Trials
856,268 Total Patients Enrolled
2 Trials studying Gastric Outlet Obstruction
118 Patients Enrolled for Gastric Outlet Obstruction
Johns Hopkins UniversityLead Sponsor
2,316 Previous Clinical Trials
14,872,711 Total Patients Enrolled
Mouen A. Khashab, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Lumen-apposing metal stent (Stent) Clinical Trial Eligibility Overview. Trial Name: NCT03259763 — N/A
Gastric Outlet Obstruction Research Study Groups: EUS-guided gastroenterostomy (EUS-GE), Enteral Stenting (ES)
Gastric Outlet Obstruction Clinical Trial 2023: Lumen-apposing metal stent Highlights & Side Effects. Trial Name: NCT03259763 — N/A
Lumen-apposing metal stent (Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03259763 — N/A
~21 spots leftby Oct 2025