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COMPLETED
NCT03259763
NA

EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

Official title: EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2020-10-26

Completion Date

2026-01-15

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DEVICE

Lumen-apposing metal stent

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.

DEVICE

Self-expandable metal stent

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.

Locations (9)

Yale University

New Haven, Connecticut, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Wake Forest Baptist University

Winston-Salem, North Carolina, United States

The Research Institute of McGill University Health Centre

Montreal, Quebec, Canada

Ecuadorian Institute of Digestive Diseases (IECED)

Guayaquil, Ecuador

Hospital Prive des Peupliers

Paris, France

Asian Institute of Gastroenterology

Hyderabad, India

Emek Medical Center

Afula, Israel

Hospital Universitario Rio Hortega

Valladolid, Spain