A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
Primary objective is to investigate the safety and effectiveness of the AXIOS™ lumen-apposing Metal Stent used in the EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for the management of symptoms associated with gastric outlet obstruction (GOO) secondary to malignant unresectable neoplasm. Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
51
EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
GOOSS 3 rate without MAE
GOOSS 3 rate without MAE
Time frame: 30 days post index-procedure
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Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan