This phase II trial studies two procedures, endoscopic ultrasonography (EUS)-guided gastroenterostomy and enteral stenting, to see how well they work in relieving symptoms and reducing suffering (palliation) for patients with malignant gastric outlet obstruction. EUS-guided gastroenterostomy is a procedure where the stomach and the adjacent small intestine are pierced by an electric needle to make a connection between them, and then a lumen-apposing metal stent (LAMS), which is like a small metallic tube, is deployed at the pierced site to keep the connection open. Enteral stenting is a procedure where a thin guidewire is advanced through the stomach obstruction and then a self-expandable metal stent (SEMS), which is like a small metallic tube, is deployed inside the obstructed part of the stomach to serve as a connection between the stomach and the small intestine. This trial studies the two techniques to find out which one is better than the other in terms of efficacy and safety.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03259763.
PRIMARY OBJECTIVE:
I. To compare the rate of recurrent gastric outlet obstruction (GOO) as evidenced clinically and documented endoscopically and/or radiographically following endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).
SECONDARY OBJECTIVES:
I. To compare the rates of technical success between the 2 techniques.
II. To compare the rates of clinical success between the 2 techniques.
III. To compare the rates of adverse events between the 2 techniques.
IV. To compare the severity of adverse events between the 2 techniques according to American Society of Gastrointestinal Endoscopy (ASGE) lexicon.
V. To compare the rates of persistent GOO between the 2 techniques.
VI. To compare the post-procedure length of hospital stay between the 2 techniques.
VII. To compare the rates of reintervention for recurrent GOO between the 2 techniques.
VIII. To compare the quality of life change (preintervention versus [vs] 1 month) between the 2 techniques.
IX. To compare the overall survival between the 2 techniques.
X. To compare the time to recurrent GOO between the 2 techniques.
XI. To compare the type of diet tolerated between the 2 techniques.
XII. To compare the length of procedure between the 2 techniques.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo EUS-GE. Patients with treatment failure may cross over to Arm II assuming a major procedural complication has not occurred that would preclude additional endoscopic intervention.
ARM II: Patients undergo endoscopic enteral stenting. Patients with treatment failure may cross over to Arm I assuming a major procedural complication has not occurred that would preclude additional endoscopic intervention.
After completion of study treatment, patients are followed up at 1 week and at 1, 2, 3, 6, and 12 months.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMouen Khashab
