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

Orlando Health, Inc.

Status: Active, not recruiting

Conditions: Gastric Outlet Obstruction

Treatments: Procedure: EUS-guided gastrojejunostomy; Procedure: Surgical gastrojejunostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05548114

22.127.06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

EUS-guided gastrojejunostomy

Active Comparator group

Description:

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

Treatment:

Procedure: EUS-guided gastrojejunostomy

Surgical gastrojejunostomy

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical gastrojejunostomy