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

NCT ID: NCT07230665

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-14
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Endoscopic ultrasound-guided gastroenterostomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nataional Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202108046RINC

Identifier Type: -

Identifier Source: org_study_id