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

Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting: a Prospective Cohort Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Endoscopy, Digestive System; Gastric Outlet Obstruction Due to Malignancy; EUS Guided Enteroenteric Anastomosis
• Intervention / Treatment: Procedure: Endoscopic ultrasound-guided gastroenterostomy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Nataional Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This multicenter prospective study involved 13 academic centers in Taiwan

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention rate	Defined as the need for additional endoscopic treatment due to recurrent GOO symptoms	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Successful stent placement across or bypass the obstruction, confirmed by endoscopy or fluoroscopy	one year
Adverse events (AEs)	AEs, including stent misdeployement, perforation, and bleeding, were classified and graded according to the Adverse Events in GI Endoscopy (AGREE) classification, with a 30-day cut-off distinguishing early and late events.	one year
Survival	alive until the last follow-up	one year
Clinical success	≥ 2 point improvement in the gastric outlet obstruction score (GOOS) after stent insertion;; GOOS categorized oral intake into four levels (the minimum and maximum score from 0 to 3): 0 (fasting), 1 (liquid diet), 2 (soft diet), and 3 (normal/low-residue diet).	one year
Gastric outlet obstruction score (GOOS) changes	GOOS categorized oral intake into four levels (the minimum and maximum score from 0 to 3): 0 (fasting), 1 (liquid diet), 2 (soft diet), and 3 (normal/low-residue diet).; Comparison the GOOS change before and after stent placement (GOOS recored while the patients was discharge)	one year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 202108046RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No