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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is comparing two endoscopic techniques for treating gastric outlet obstruction, which is a common complication of luminal malignancies.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a cancer-caused blockage in my stomach that cannot be surgically removed.
Select...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of gastric outlet obstruction recurrence
Secondary outcome measures
Adverse events rate
Clinical success rate
Duration of stent patency
+9 moreTrial 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.
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
932,810 Total Patients Enrolled
2 Trials studying Gastric Outlet Obstruction
110 Patients Enrolled for Gastric Outlet Obstruction
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,053 Total Patients Enrolled
Mouen A. Khashab, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a cancer-caused blockage in my stomach that cannot be surgically removed.I have a large amount of fluid in my abdomen.My cancer has spread to my stomach, duodenum, or near the ligament of Treitz.I have had surgery on my stomach or the beginning of my small intestine.I spend all my time in bed due to my condition.I am unable to understand or sign the consent form.An endoscopy technique cannot be used on me, as decided by my doctor.I cannot eat or drink normally due to a blockage in my stomach.My tumor can possibly be removed with surgery.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: EUS-guided gastroenterostomy (EUS-GE)
- Group 2: Enteral Stenting (ES)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being monitored as part of this research?
"Affirmative. Clinicaltrials.gov reports that this research effort, which was first made public on October 26th 2020, is recruiting participants as we speak. 112 individuals are expected to join the trial from a single medical facility."
Answered by AI
Is there still capacity for new participants in this clinical experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, this trial is presently recruiting participants who meet its criteria. It was initially advertised on October 26th 2020 and has been updated as recently as December 8th 2021 with a goal of enrolling 112 patients across one medical facility."
Answered by AI
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