Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Vanderbilt University Medical Center

Status: Invitation-only

Conditions: Malignant Gastric Outlet Obstruction

Treatments: Procedure: EUS Gastrojejunostomy; Procedure: Surgical Gastrojejunostomy; Other: Gastric Outlet Obstruction Scoring System (GOOSS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06567691

240747

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

EUS Gastrojejunostomy

Active Comparator group

Description:

Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure

Treatment:

Other: Gastric Outlet Obstruction Scoring System (GOOSS)

Procedure: EUS Gastrojejunostomy

Surgical Gastrojejunostomy

Active Comparator group

Description:

Patient will undergo Surgical Gastrojejunostomy procedure.

Treatment:

Other: Gastric Outlet Obstruction Scoring System (GOOSS)

Procedure: Surgical Gastrojejunostomy