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

The Chinese University of Hong Kong

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Cholecystitis

Treatments: Procedure: Percutaneous cholecystostomy (PC); Procedure: EUS-guided gallbladder drainage (EGBD)

Study type: Interventional

Funder types: Other

Identifiers

NCT02212717

CREC-2014.301-T

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

EUS-guided gallbladder drainage

Active Comparator group

Treatment:

Procedure: EUS-guided gallbladder drainage (EGBD)

Percutaneous cholecystomy

Active Comparator group

Treatment:

Procedure: Percutaneous cholecystostomy (PC)