The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
Official Title: EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
Study ID: NCT03259763
Brief Summary: Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).
Detailed Description: In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions. Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale University, New Haven, Connecticut, United States
The Johns Hopkins Hospital, Baltimore, Maryland, United States
Brigham & Women's Hospital - Harvard, Boston, Massachusetts, United States
NYU Langone Health, New York, New York, United States
Columbia University, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Wake Forest Baptist University, Winston-Salem, North Carolina, United States
The Research Institute of McGill University Health Centre, Montréal, Quebec, Canada
Ecuadorian Institute of Digestive Diseases (IECED), Guayaquil, , Ecuador
Limoges University Hospital, Limoges, , France
Hospital Prive des Peupliers, Paris, , France
Asian Institute of Gastroenterology, Hyderabad, , India
Hospital Universitario Rio Hortega, Valladolid, , Spain
Name: Mouen A. Khashab, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR