Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting

National Taiwan University

Status: Invitation-only

Conditions: EUS Guided Enteroenteric Anastomosis; Gastric Outlet Obstruction Due to Malignancy; Endoscopy, Digestive System

Treatments: Procedure: Endoscopic ultrasound-guided gastroenterostomy

Study type: Observational

Funder types: Other

Identifiers

NCT07230665

202108046RINC

Details and patient eligibility

About

Gastric outlet obstruction (GOO) refers to a mechanical blockage of the distal stomach or duodenum that prevents normal passage of food and liquids. According to literature, 50-80% of GOO cases are caused by malignant tumors compressing or directly invading the gastrointestinal tract. Among patients with pancreatic cancer, 15-20% develop GOO [1,2]. GOO is also considered a poor prognostic factor in malignancy, with a median survival time of only 3-6 months [3].

Traditionally, management options for GOO include surgical gastrojejunostomy and endoscopic enteral metal stent (ES) placement. Endoscopic approaches are less invasive, allow earlier oral intake, and reduce hospital stay [4-6]. Considering that most patients with malignant GOO are debilitated, a less invasive option is often preferable.

In recent years, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) has emerged as an alternative. A recent systematic review and meta-analysis comparing ES and EUS-GE found similar technical and clinical success rates, but significantly lower re-intervention rates in the EUS-GE group [7]. However, most existing studies are retrospective and lack systematic, prospective follow-up data comparing the two approaches remain lacking.

This study aims to prospectively evaluate and compare the short- and long-term outcomes-including stent function, oral intake, nutritional status, and quality of life-of patients with malignant GOO undergoing either EUS-GE or conventional enteral stenting.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients aged 18 years or older who underwent ES or EUS-GE for unresectable mGOO were enrolled

Exclusion criteria

• Prior enteral stent placement
• Multi-level bowel obstruction,
• Linitis plastica of the stomach
• A life expectancy of less than one mont
• Uncorrected coagulopathy
• Pregnancy
• Inability to provide informed consent

Trial design

200 participants in 1 patient group

Endoscopic enteral stent placement

Description:

This procedure was performed under fluoroscopic guidance. Either a duodenoscope or a forward-viewing therapeutic endoscope was used to access the obstruction. A 0.025-or 0.035-inch guidewire was advanced into the jejunum beyond the obstruction using a 20mm extraction balloon catheter. After positioning the catheter across the stricture, contrast was injected to determine the location and length of the stricture. An uncovered, through-the-scope duodenal stent (BONASTENT; Standard Sci Tech, Seoul, Korea or WallFlex; Boston Scientific, Marlborough, Mass, USA) with a diameter of 22 mm and a length of 6 to 16 cm, depending on the stricture length, was then deployed to adequately cover both ends of the obstruction under combined fluoroscopic and endoscopic guidance.

Treatment:

Procedure: Endoscopic ultrasound-guided gastroenterostomy