Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
- Conditions
- Gastric Outlet Obstruction
- Interventions
- Procedure: EUS-guided gastrojejunostomyProcedure: Surgical gastrojejunostomy
- Registration Number
- NCT05548114
- Lead Sponsor
- Orlando Health, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EUS-guided gastrojejunostomy EUS-guided gastrojejunostomy EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent Surgical gastrojejunostomy Surgical gastrojejunostomy A surgical gastrojejunostomy will be created via laparoscopic or open technique, as clinically appropriate.
- Primary Outcome Measures
Name Time Method 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. 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 endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.
- Secondary Outcome Measures
Name Time Method 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 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).
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 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).
Rate of technical success 24 hours Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method.
Procedure duration 24 hours Procedure duration for EUS-guided and surgical gastrojejunostomy procedures
Time to diet advancement 1 month Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3).
Time to recurrence of obstructive symptoms 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.
Rate of persistence of symptoms 6 months Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure.
Rate of reintervention 6 months Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy.
Total number of readmissions 6 months Total no. of readmissions due to disease-related symptoms or procedure-related events.
Rate of adverse events due to procedures performed 6 months Procedure-related adverse events
Rate of adverse events due to underlying disease 6 months Disease-related adverse events
Total length of hospital stay 6 months Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge.
Length of survival 6 months Duration of survival post-procedure.
Time to initiation of chemotherapy post-procedure 6 months Time to initiation of chemotherapy post-procedure
Quality of life measurement 6 months Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire.
Overall treatment costs from index procedure until 6 months post-index procedure. 6 months 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.
Trial Locations
- Locations (1)
Orlando Health
🇺🇸Orlando, Florida, United States