Status:
COMPLETED
A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
American Society for Gastrointestinal Endoscopy
Tokyo Medical University
Conditions:
Acute Cholecystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02212717
Start Date
August 1 2014
End Date
March 1 2019
Last Update
July 30 2019
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
2
Kinki University Hospital
Osaka, Japan
3
Tokyo Medical University Hospital
Tokyo, Japan
4
University Hospital Rio Hortega
Barcelona, Spain