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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery.

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.


Detailed Summary:
Sponsor: Chinese University of Hong Kong

Current Primary Outcome: Composite outcome of all morbidities, re-interventions and mortalities [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical success [ Time Frame: 30 days ]
    Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.
  • Pain scores [ Time Frame: 7 days ]
    Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
  • Analgesic requirements [ Time Frame: 7 days ]
    The amount of analgesic consumed during admission will be recorded and compared between groups. Oral panadol and intravenous tramadol (or equivalent) would be provided as required to patients.
  • Stone clearance rates [ Time Frame: 2 years ]
    The presence or absence of gallstones after 2 years would be assessed by abdominal ultrasonography
  • Clinical success [ Time Frame: 30 days ]
    Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.


Original Secondary Outcome: Same as current

Information By: Chinese University of Hong Kong

Dates:
Date Received: August 5, 2014
Date Started: August 2014
Date Completion: August 2018
Last Updated: November 16, 2016
Last Verified: November 2016