NCT06128018 · AdventHealth
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
(RESTORE)
What this study is about
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
View original scientific description
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 18 years of age.
- Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
- GOOSS of 0 or 1
- BOTH surgical and endoscopic GJ are technically and clinically feasible
- 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
- \< 18 years of age
- Expected survival (determined by the treating oncologist) is less than 2 months.
- Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
- Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
- Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
- 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)
Where
- Orlando, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations