Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Not Applicable

Not yet recruiting

• Conditions: Malignant Gastric Outlet Obstruction
• Interventions: Procedure: EUS Gastrojejunostomy; Procedure: Surgical Gastrojejunostomy; Other: Gastric Outlet Obstruction Scoring System (GOOSS)

• Registration Number: NCT06567691
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.

EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach \[4\]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Start: 2025-01
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Age 18 years or older
• Able to provide informed consent
• Biopsy-proven cancer
• Cancer without surgical resection as a curative treatment option
• Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum

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Exclusion Criteria

• Age <18 years
• Pregnancy
• Unable to provide informed consent
• White Blood Count < 3,000
• Absolute Neutrophil Count < 1,500
• International normalized ratio > 1.6
• Platelet count < 100,000
• Cancer with surgical resection as a curative treatment option
• Surgically altered foregut anatomy
• Multifocal intestinal obstruction
• Abdominal ascites prohibitive of surgical candidacy
• Abdominal wall mesh prohibitive of surgical candidacy
• Child's Class B or C cirrhosis
• Gastroesophageal varices or known portal hypertension
• Body mass index >40

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS Gastrojejunostomy	EUS Gastrojejunostomy	Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure
Surgical Gastrojejunostomy	Gastric Outlet Obstruction Scoring System (GOOSS)	Patient will undergo Surgical Gastrojejunostomy procedure.
EUS Gastrojejunostomy	Gastric Outlet Obstruction Scoring System (GOOSS)	Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure
Surgical Gastrojejunostomy	Surgical Gastrojejunostomy	Patient will undergo Surgical Gastrojejunostomy procedure.

Primary Outcome Measures

Name	Time	Method
Compare post procedure length of hospital stay	14 days post-operative	This outcome will be measured as the length of hospital stay (in days) from study intervention to discharge. Any accrued hospital stay from admission prior to study intervention will not be included in this assessment.
Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy	1 day post-operative	A GOOSS score of 0 will be defined as intolerant of oral intake, while any GOOSS score greater than 0 will be defined as tolerant of oral intake.; 0: no oral intake; 1. oral liquids only; 2. soft solids; 3. low residue or full diet This will be given to subjects

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States