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

Official title

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

Overview

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.

Interventions

• 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 pu

Primary outcome measures

• Reintervention rate [Time frame: one year]

Secondary outcome measures (5)

• Technical success [Time frame: one year]
• Clinical success [Time frame: one year]
• Gastric outlet obstruction score (GOOS) changes [Time frame: one year]
• Adverse events (AEs) [Time frame: one year]
• Survival [Time frame: one year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Taiwan · 1 center

• Nataional Taiwan University Hospital — Taipei

Publications

• Kuo YT, Yang CY, Chen JH, Liao SC, Hsieh CL, Wu CH, Lin MY, Chung CS, Chen KC, Lee MH, Shih HY, Lin JC, Sun CK, Tsai MC, Wang HP; Taiwan EUS-GE Study Group (TEGESG). EUS-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction: Morphological Classification to Prevent Stent Misdeployment. Dig Endosc. 2026 Jul;38(7):e70235. doi: 10.1111/den.70235. PMID 42466906

Identifiers

NCT: NCT07230665 · 202108046RINC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗