EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Study Overview
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Brief Summary
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Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

Detailed Description
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In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions. Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.

Official Title
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EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial

Conditions
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Gastric Outlet Obstruction

Intervention / Treatment
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* Device: Lumen-apposing metal stent
* Device: Self-expandable metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only) Age 18-80 years Exclusion Criteria: Evidence of other strictures in the gastrointestinal (GI) tract Previous gastric, periampullary or duodenal surgery World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed) Unable to fill out quality of life questionnaire Unable to sign the informed consent Life expectancy of less than 3 months based on the endoscopist's opinion Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal jejunum around the ligament of Treitz Large volume ascites Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other severe comorbidities Pregnant or breastfeeding women Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50000/µl Complete GOO evidenced by inability to either pass a wire across the stricture and/or inability to opacify small bowel distal to the malignant stricture Resectable or borderline resectable tumors One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of the endoscopist)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-guided gastroenterostomy (EUS-GE)<br>In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open. | Device: Lumen-apposing metal stent<br>* In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.<br>|
| Active Comparator: Enteral Stenting (ES)<br>In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance. | Device: Self-expandable metal stent<br>* In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of gastric outlet obstruction recurrence | Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically. | Day of procedure | 
| Clinical success rate | The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion. | 1 week | 
| Length of procedure |  | Day of procedure | 
| Adverse events rate |  | 1 week | 
| Post-procedure length of hospital stay |  | 1 week | 
| Reintervention rate for recurrent gastric outlet obstruction |  | 3 months | 
| Quality of Life SF-36 questionnaire scoring | The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life. | 3 months | 
| Overall survival rate |  | 1 year | 
| Time to recurrent gastric outlet obstruction |  | 3 months | 
| Gastric Outlet Obstruction Scoring system (GOOSS) | Diet toleration will be scored based on the Gastric Outlet Obstruction Scoring System (GOOSS). The scoring ranges from 0 to 3 in the following format: 0 = no oral intake, 1 = liquids only, 2 = soft solids, 3 = low-residue or full diet | 1 year | 
| Stent Dysfunction Rate | the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture | 3 months | 
| Duration of stent patency | Calculated from the time of stent placement to the time of stent dysfunction | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenterostomy, Gastric Outlet Obstruction, Cancer, Endosonography