What side effects are associated with this type of intervention?

Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and Enteral Stenting (ES) are minimally invasive treatments for gastric outlet obstruction. Common side effects of EUS-GE include peritonitis, bleeding, and the need for surgical intervention in some cases. For Enteral Stenting, side effects can include stent migration, tumor ingrowth, and sludge formation. Both procedures aim to alleviate obstruction but come with risks of adverse events that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Gastric Outlet Obstruction (GOO) that align with the techniques being studied in the trial. Enteral stenting (ES) is a well-established, FDA-approved method for palliation of malignant GOO, involving the placement of self-expandable metallic stents (SEMS) to keep the obstructed lumen open. This method is widely accepted due to its minimally invasive nature and effectiveness in relieving symptoms. While Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a newer technique and may not yet have specific FDA approval, it represents an innovative approach to creating a bypass between the stomach and small intestine, offering a less invasive alternative to surgical bypass.

What other types of research exist?

Promising novel alternatives to EUS-GE and ES for treating Gastric Outlet Obstruction (GOO) include gastric per-oral endoscopic myotomy (G-POEM) and laparoscopic pyloroplasty. G-POEM involves endoscopic cutting of the pyloric muscle to improve gastric emptying and has shown efficacy with lower complication rates and shorter hospital stays compared to surgical myotomy. Laparoscopic pyloroplasty, a minimally invasive surgical procedure to widen the pyloric canal, also shows promise in treating GOO with good outcomes.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met

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.