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Enrolling by Invitation

NCT Number: NCT07230665

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nataional Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reintervention rate

    Time frame: one year

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

Secondary outcomes

  1. Technical success

    Time frame: one year

    Successful stent placement across or bypass the obstruction, confirmed by endoscopy or fluoroscopy

  2. Clinical success

    Time frame: one year

    • ≥ 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).

  3. Gastric outlet obstruction score (GOOS) changes

    Time frame: one year

    • 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)

  4. Adverse events (AEs)

    Time frame: one year

    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.

  5. Survival

    Time frame: one year

    alive until the last follow-up

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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