EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Johns Hopkins University

Status: Active, not recruiting

Conditions: Gastric Outlet Obstruction

Treatments: Device: Lumen-apposing metal stent; Device: Self-expandable metal stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03259763

IRB00128878

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

EUS-guided gastroenterostomy (EUS-GE)

Active Comparator group

Description:

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.

Treatment:

Device: Lumen-apposing metal stent

Enteral Stenting (ES)

Active Comparator group

Description:

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.

Treatment:

Device: Self-expandable metal stent