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Endoscopic vs Surgical Procedures for Gastric Outlet Obstruction

N/A
Waitlist Available
Led By Patrick Yachimski, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum
Age 18 years or older
Must not have
Age <18 years
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days post-operative
Awards & highlights

Summary

This trial compares two procedures for treating a condition called malignant gastric outlet obstruction (GOO). The study found that EUS gastroenterostomy had better long-term results compared to enteral stents.

Who is the study for?
This trial is for individuals with gastric outlet obstruction, a condition where the stomach's exit to the small intestine is blocked. Participants should be suitable candidates for either endoscopic or surgical procedures to create a new connection between the stomach and small intestine.
What is being tested?
The study compares two treatments: EUS gastroenterostomy (a non-surgical procedure using an endoscope) and surgical gastrojejunostomy (an operation). It aims to determine which method provides better outcomes for patients with malignant gastric outlet obstruction.
What are the potential side effects?
Potential side effects may include pain, infection, bleeding, or complications related to anesthesia. The endoscopic approach might have fewer side effects like reduced recovery time compared to surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is blocking the upper part of my stomach or beginning of my small intestine.
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I am 18 years old or older.
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My cancer cannot be cured by surgery alone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am unable to understand and give consent for treatment.
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I have multiple blockages in my intestines.
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My liver disease is severe (Child-Pugh B or C).
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I cannot have surgery because of mesh in my abdominal wall.
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My cancer can potentially be cured with surgery.
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I have had surgery on my upper digestive tract.
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I have varicose veins in my esophagus or high blood pressure in the liver.
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I cannot have surgery due to fluid in my abdomen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy
Compare post procedure length of hospital stay

Trial Design

2Treatment groups
Active Control
Group I: EUS GastrojejunostomyActive Control2 Interventions
Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure
Group II: Surgical GastrojejunostomyActive Control2 Interventions
Patient will undergo Surgical Gastrojejunostomy procedure.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,900 Total Patients Enrolled
Patrick Yachimski, MDPrincipal InvestigatorVanderbilt University Medical Center
~23 spots leftby Oct 2026
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