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Gastrojejunostomy Techniques for Gastric Outlet Obstruction

N/A

Recruiting

Led By Ji Young Bang, MD MPH

Research Sponsored by Orlando Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy

Must not have

Use of anticoagulants that cannot be discontinued for the procedure

Age < 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the outcomes of two treatments for a cancer that is blocking the stomach from emptying into the small intestine.

Who is the study for?

This trial is for adults over 18 with gastric outlet obstruction due to cancer, who can only consume liquids. It's not for those under 18, pregnant women, or patients on anticoagulants that can't be stopped.

What is being tested?

The study compares two procedures in patients with malignant gastric outlet obstruction: EUS-guided gastrojejunostomy (a less invasive endoscopic procedure) and traditional surgical gastrojejunostomy.

What are the potential side effects?

Possible side effects include pain at the procedure site, infection risk, bleeding complications especially if previous anticoagulant use isn't properly managed, and potential anesthesia-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a blockage in my stomach due to cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on blood thinners that cannot be stopped for a procedure.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.

Secondary study objectives

Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

Length of survival

+12 more