Recruiting

Endoscopic Ultrasound vs. Surgical Gastrojejunostomy

Sponsor:

AdventHealth

Code:

NCT06128018

Conditions

Malignant Gastric Outlet Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical gastrojejunostomy (S-GJ)

EUS-guided gastrojejunostomy (EUS-GJ)

Study Details

Brief summary:

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.

Conditions

Malignant Gastric Outlet Obstruction

Study ID

NCT06128018

Start date

Nov 1, 2023

Status verified date

Apr, 2026

Completion date

Mar 8, 2027

Anticipated

Primary completion date

Sep 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 18 years of age.
2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
3. GOOSS of 0 or 1
4. BOTH surgical and endoscopic GJ are technically and clinically feasible
5. Can understand and is willing to sign informed consent form prior to the initiation of any study procedures (or when applicable the subject's LAR).

Exclusion Criteria:

1. < 18 years of age
2. ECOG >2
3. Expected survival (determined by the treating oncologist) is less than 2 months.
4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
7. Anatomical factors that technically hinder EUS-GJ OR Surgical-GJ (diffuse tumor involvement in path of LAMS or surgery, surgically altered anatomy that interferes with the ability to perform an anastomosis etc)
8. Pregnancy

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: EUS-guided gastrojejunostomy (EUS-GJ)

Patients on this arm will undergo the endoscopic procedure.

other: Surgical gastrojejunostomy (S-GJ)

Patients on this arm will undergo the surgical procedure.

Interventions

Surgical gastrojejunostomy (S-GJ)

Surgical gastro-jejunostomy

EUS-guided gastrojejunostomy (EUS-GJ)

Endoscopic Ultrasound guided gastro-jejunostomy

Primary outcome measure

  • Identify safety profile EUS-GJ [ Time Frame: 24 Months ]

Central Contacts and Locations

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32804

Contacts

Principal Investigator:

Kambiz Kadkhodayan, MD

More Information

Sponsor

AdventHealth

Last update posted

Sep 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-09-04.