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