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NCT Number: NCT05548114

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Outlet Obstruction Digestive System Diseases Gastrointestinal Diseases Neoplasms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health

Orlando, Florida, 32806, United States

About this study

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
  • Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
  • Amenable to treatment by both EUS-guided and surgical gastrojejunostomy

Exclusion criteria

  • Age < 18 years
  • Intrauterine pregnancy
  • Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
  • Unable to obtain consent for the procedure from either the patient or LAR
  • Altered anatomy due to prior gastroduodenal surgery
  • Presence of other adhesions or synchronous obstructive lesions in the small bowel
  • Prior treatment for gastric outlet obstruction
  • Presence of large volume malignant ascites

Treatment and study plan

EUS-guided gastrojejunostomy

Procedure

AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.

Surgical Gastrojejunostomy

Procedure

A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.

Primary outcomes

  1. Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.

    Time frame: 6 months

    Proportion of patients unable to tolerate a solid diet at time of hospital discharge (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.

Secondary outcomes

  1. Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

    Time frame: 6 months

    Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

  2. Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

    Time frame: 6 months

    Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

  3. Rate of technical success

    Time frame: 24 hours

    Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method.

  4. Procedure duration

    Time frame: 24 hours

    Procedure duration for EUS-guided and surgical gastrojejunostomy procedures

  5. Time to diet advancement

    Time frame: 1 month

    Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3).

  6. Time to recurrence of obstructive symptoms

    Time frame: 6 months

    Recurrence of obstructive symptoms, defined as the recurrence of obstructive symptoms (GOOSS score ≤ 1) after achieving GOOSS ≥ 2 for at least 7 days at any time during follow-up.

  7. Rate of persistence of symptoms

    Time frame: 6 months

    Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure.

  8. Rate of reintervention

    Time frame: 6 months

    Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy.

  9. Total number of readmissions

    Time frame: 6 months

    Total no. of readmissions due to disease-related symptoms or procedure-related events.

  10. Rate of adverse events due to procedures performed

    Time frame: 6 months

    Procedure-related adverse events

  11. Rate of adverse events due to underlying disease

    Time frame: 6 months

    Disease-related adverse events

  12. Total length of hospital stay

    Time frame: 6 months

    Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge.

  13. Length of survival

    Time frame: 6 months

    Duration of survival post-procedure.

  14. Time to initiation of chemotherapy post-procedure

    Time frame: 6 months

    Time to initiation of chemotherapy post-procedure

  15. Quality of life measurement

    Time frame: 6 months

    Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire.

  16. Treatment costs

    Time frame: 6 months

    All relevant costs pertaining to treatment of gastric outlet obstruction will be taken into consideration from index intervention to hospital discharge: procedure costs, inpatient hospital stay from date of procedure to discharge, medications, materials, anesthesia, pharmacy and imaging studies.

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Collaborators

  • Asian Institute of Gastroenterology, India
  • Medanta, The Medicity, India
  • Rush University
  • University of Hamburg-Eppendorf
  • West Virginia University

Registry information

Official study title

Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2022
Registry last updated
Jun 12, 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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