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

NCT07230665 | Enrolling By Invitation

• 1 other identifier: 202108046RINC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Reintervention rate

  Defined as the need for additional endoscopic treatment due to recurrent GOO symptoms

  one year

Secondary Outcomes (5)

• Technical success

  one year

• Clinical success

  one year

• Gastric outlet obstruction score (GOOS) changes

  one year

• Adverse events (AEs)

  one year

• Survival

  one year

Study Arms (1)

Endoscopic enteral stent placement

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.

Procedure: Endoscopic ultrasound-guided gastroenterostomy

Interventions

Endoscopic ultrasound-guided gastroenterostomy PROCEDURE

This procedure was performed under general anesthesia with endotracheal intubation. After identifying the site and extent of the obstruction similar with ES, a 7Fr nasobiliary drain was advanced over the guidewire into the target jejunum under fluoroscopic guidance. A linear echoendoscope was then advanced into the stomach to visualize the jejunum. The jejunal loop was adequately distended by continuously infusing a mixture of saline, contrast medium, and indigo carmine using a standard water pump. Once the target jejunum was confirmed, an antispasmodic was administered. Using the freehand technique, the gastric and jejunal walls were directly punctured with an electrocautery- enhanced LAMS (Hot AXIOS, 20 mm diameter, 10 mm length; Boston Scientific). The LAMS was deployed under EUS and fluoroscopic guidance-first the distal flange into the jejunum, followed by intrachannel release of the proximal flange within the echoendoscope, and then its advancement outside the working channel.

Endoscopic enteral stent placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This multicenter prospective study involved 13 academic centers in Taiwan

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Nataional Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: August 14, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

TW (1)