A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

February 28, 2018

Study Completion Date

March 31, 2019

Conditions
Acute Cholecystitis
Interventions
PROCEDURE

EUS-guided gallbladder drainage (EGBD)

The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent.

PROCEDURE

Percutaneous cholecystostomy (PC)

Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag.

Trial Locations (4)

Unknown

Chinese University of Hong Kong, Hong Kong

Kinki University Hospital, Osaka

Tokyo Medical University Hospital, Tokyo

University Hospital Rio Hortega, Barcelona

All Listed Sponsors
collaborator

American Society for Gastrointestinal Endoscopy

OTHER

collaborator

Tokyo Medical University

OTHER

collaborator

Kinki University

OTHER

collaborator

University of Barcelona

OTHER

lead

Chinese University of Hong Kong

OTHER

NCT02212717 - A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. | Biotech Hunter | Biotech Hunter