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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2025-12-31

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 aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

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Detailed Description

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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.

Conditions

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Gastric Outlet Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EUS-guided gastrojejunostomy

EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent

Group Type ACTIVE_COMPARATOR

EUS-guided gastrojejunostomy

Intervention Type PROCEDURE

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 or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.

Group Type ACTIVE_COMPARATOR

Surgical gastrojejunostomy

Intervention Type PROCEDURE

A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.

Interventions

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EUS-guided gastrojejunostomy

AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.

Intervention Type PROCEDURE

Surgical gastrojejunostomy

A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy

Exclusion Criteria

1. Age \< 18 years
2. Intrauterine pregnancy
3. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
4. Unable to obtain consent for the procedure from either the patient or LAR
5. Altered anatomy due to prior gastroduodenal surgery
6. Presence of other adhesions or synchronous obstructive lesions in the small bowel
7. Prior treatment for gastric outlet obstruction
8. Presence of large volume malignant ascites

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No