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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastric Outlet Obstruction

Intervention / Treatment
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* Procedure: EUS-guided gastrojejunostomy
* Procedure: Surgical gastrojejunostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only) Exclusion Criteria: Age < 18 years Intrauterine pregnancy Use of anticoagulants that cannot be discontinued for the procedure Unable to obtain consent for the procedure from either the patient or LAR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-guided gastrojejunostomy<br>EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent | Procedure: EUS-guided gastrojejunostomy<br>* AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.<br>|
| Active Comparator: Surgical gastrojejunostomy<br>A surgical gastrojejunostomy will be created via laparoscopic or open technique, as clinically appropriate. | Procedure: Surgical gastrojejunostomy<br>* A surgical gastrojejunostomy will be created via laparoscopic (preferred) or open technique, as clinically appropriate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Rate of technical success | Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method. | 24 hours | 
| Procedure duration | Procedure duration for EUS-guided and surgical gastrojejunostomy procedures | 24 hours | 
| 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 | 
| 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 | 
| Rate of persistence of symptoms | Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure. | 6 months | 
| 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 | 
| Total number of readmissions | Total no. of readmissions due to disease-related symptoms or procedure-related events. | 6 months | 
| Rate of adverse events due to procedures performed | Procedure-related adverse events | 6 months | 
| Rate of adverse events due to underlying disease | Disease-related adverse events | 6 months | 
| 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 | 
| Length of survival | Duration of survival post-procedure. | 6 months | 
| Quality of life measurement | Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire. | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Gastric outlet obstruction, Endoscopic ultrasound, Malignancy, Gastrojejunostomy