Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Launched by ADVENTHEALTH · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two different methods for treating a serious condition called malignant gastric outlet obstruction (GOO), which happens when a tumor blocks the passage from the stomach to the intestines. The study aims to compare endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) with traditional surgical gastrojejunostomy to see which method offers better outcomes for patients. If you or a loved one is between 18 and 74 years old and has evidence of an obstructing tumor in the stomach or duodenum, you may be eligible to participate, provided your overall health allows for both methods to be performed.

Participants in the trial will be randomly assigned to receive either the endoscopic or surgical procedure, and they will be monitored to see how well each approach works. It’s important to note that certain conditions, such as severe health issues or specific types of cancer, may exclude someone from joining the study. If you decide to participate, you will need to understand and agree to the study details by signing a consent form. This trial is currently recruiting participants, and it offers a chance to contribute to important medical research that could help improve treatment options for others facing similar health challenges.

Gender

ALL

Eligibility criteria

• 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