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

Gastric Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548114
• Other study ID #: 22.127.06
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Orlando Health, Inc.
• Contact: Ji Young Bang, MD, MPH
• Phone: 321-841-2431
• Email: jiyoung.bang[@]orlandohealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy

3. Gastric outlet obstruction Scoring System (GOOSS) of = 1 (defined as maximum oral intake of liquids only)

Exclusion Criteria:

1. Age < 18 years

2. Intrauterine pregnancy

3. Use of anticoagulants that cannot be discontinued for the procedure

4. Unable to obtain consent for the procedure from either the patient or LAR

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Procedure:
• EUS-guided gastrojejunostomy
AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
• Surgical gastrojejunostomy
A surgical gastrojejunostomy will be created via laparoscopic (preferred) or open technique, as clinically appropriate.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Orlando Health, Inc.	Rush University, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.	Proportion of patients unable to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.	6 months
Secondary	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).	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).	6 months
Secondary	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).	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).	6 months
Secondary	Rate of technical success	Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method.	24 hours
Secondary	Procedure duration	Procedure duration for EUS-guided and surgical gastrojejunostomy procedures	24 hours
Secondary	Time to diet advancement	Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3).	1 month
Secondary	Time to recurrence of obstructive symptoms	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.	6 months
Secondary	Rate of persistence of symptoms	Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure.	6 months
Secondary	Rate of reintervention	Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy.	6 months
Secondary	Total number of readmissions	Total no. of readmissions due to disease-related symptoms or procedure-related events.	6 months
Secondary	Rate of adverse events due to procedures performed	Procedure-related adverse events	6 months
Secondary	Rate of adverse events due to underlying disease	Disease-related adverse events	6 months
Secondary	Total length of hospital stay	Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge.	6 months
Secondary	Length of survival	Duration of survival post-procedure.	6 months
Secondary	Quality of life measurement	Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire.	6 months
Secondary	Overall treatment costs from index procedure until 6 months post-index procedure.	All relevant costs pertaining to treatment of gastric outlet obstruction will be taken into consideration: procedure costs, inpatient hospital stay from date of procedure to discharge, readmissions, medications, materials, anesthesia, pharmacy and imaging studies.	6 months