Brief Title
A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.
Official Title
Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.
Brief Summary
Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in treatment of this condition has been demonstrated but how the two procedures compare to one another is uncertain. The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Overall morbidities
Secondary Outcome
Technical success
Condition
Acute Cholecystitis
Intervention
EUS-guided gallbladder drainage (EGBD)
Study Arms / Comparison Groups
EUS-guided gallbladder drainage
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
60
Start Date
August 2014
Completion Date
March 2019
Primary Completion Date
February 2018
Eligibility Criteria
Inclusion Criteria: - Consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions including: American society of anesthesiology grading ≥ 3, APACHE score ≥ 12, limited life expectancy (less than 2 years) or deemed unsuitable for general anesthesia would be included. - Written informed consent from patient or guardian who is able to understand the nature and possible consequences of the study Exclusion Criteria: - Pregnancy - Patients unwilling to undergo follow-up assessments - Patients with suspected gangrene or perforation of the gallbladder - Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal) - Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum - Patients with liver cirrhosis, portal hypertension and/or gastric varices - Abnormal coagulation: INR > 1.5 and/or platelets < 50.000/mm3 - Previous drainage of the gallbladder
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02212717
Organization ID
CREC-2014.301-T
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Collaborators
American Society for Gastrointestinal Endoscopy
Study Sponsor
, ,
Verification Date
July 2019