Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

NCT ID: NCT06567691

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-01-31

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.

Conditions

Malignant Gastric Outlet Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

EUS Gastrojejunostomy

Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure

Group Type: ACTIVE_COMPARATOR

EUS Gastrojejunostomy

Intervention Type: PROCEDURE

Endoscopic Ultrasound (EUS) Gastrojejunostomy. Under live real-time EUS visualization, a solution of normal saline or water and dilute methylene blue will be infused through the nasobiliary drainage catheter to mechanically distend the small intestine and create a suitable, expanded fluid-filled target for transgastric access. Once a suitable target has been identified, a lumen apposing metal stent (LAMS) will then be deployed securely across the newly created gastroenterostomy tract. Appropriate stent placement will be confirmed.

Gastric Outlet Obstruction Scoring System (GOOSS)

Intervention Type: OTHER

A previously validated instrument for assessing tolerance of oral intake.

Surgical Gastrojejunostomy

Patient will undergo Surgical Gastrojejunostomy procedure.

Group Type: ACTIVE_COMPARATOR

Surgical Gastrojejunostomy

Intervention Type: PROCEDURE

Gastrojejunostomy will be performed via an open technique using an upper midline or left sub-costal incision (at the discretion of the surgeon). An antecolic, pro-peristaltic, gastrojejunostomy will be performed using one of two standard techniques: 1) hand-sewn: 2-layer anastomosis using absorbable suture or 2) stapled: single-layer anastomosis using a surgical stapler with closed staple height ranging from 1.0 - 1.5 mm and suture closure of the common enterotomy. Feeding tube placement will be at the discretion of the operating surgeon and if performed, will be performed via a Stamm technique. Abdominal fascial closure will be performed with absorbable, monofilament, suture and skin will be closed using staples or suture at the discretion of the surgeon.

Gastric Outlet Obstruction Scoring System (GOOSS)

Intervention Type: OTHER

A previously validated instrument for assessing tolerance of oral intake.

Interventions

EUS Gastrojejunostomy

Endoscopic Ultrasound (EUS) Gastrojejunostomy. Under live real-time EUS visualization, a solution of normal saline or water and dilute methylene blue will be infused through the nasobiliary drainage catheter to mechanically distend the small intestine and create a suitable, expanded fluid-filled target for transgastric access. Once a suitable target has been identified, a lumen apposing metal stent (LAMS) will then be deployed securely across the newly created gastroenterostomy tract. Appropriate stent placement will be confirmed.

Intervention Type: PROCEDURE

Surgical Gastrojejunostomy

Gastrojejunostomy will be performed via an open technique using an upper midline or left sub-costal incision (at the discretion of the surgeon). An antecolic, pro-peristaltic, gastrojejunostomy will be performed using one of two standard techniques: 1) hand-sewn: 2-layer anastomosis using absorbable suture or 2) stapled: single-layer anastomosis using a surgical stapler with closed staple height ranging from 1.0 - 1.5 mm and suture closure of the common enterotomy. Feeding tube placement will be at the discretion of the operating surgeon and if performed, will be performed via a Stamm technique. Abdominal fascial closure will be performed with absorbable, monofilament, suture and skin will be closed using staples or suture at the discretion of the surgeon.

Intervention Type: PROCEDURE

Gastric Outlet Obstruction Scoring System (GOOSS)

A previously validated instrument for assessing tolerance of oral intake.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Patrick Yachimski

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Yachimski, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

240747

Identifier Type: -

Identifier Source: org_study_id