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

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ClinicalTrials.gov Identifier: NCT02212717
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
Tokyo Medical University
Kinki University
University of Barcelona
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE August 8, 2014
Last Update Posted Date July 30, 2019
Study Start Date  ICMJE August 2014
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Overall morbidities [ Time Frame: 1 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
Composite outcome of all morbidities, re-interventions and mortalities [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • 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: 1 years ]
    The presence or absence of gallstones after 1 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.
  • Reintervention rate [ Time Frame: 1 year ]
    The number of patients requiring biliary related re-interventions within 1 year
  • Re-admission rate [ Time Frame: 1 year ]
    The number of patients requiring hospital re-admissions due to biliary related events
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Cholecystitis
Intervention  ICMJE
  • Procedure: EUS-guided gallbladder drainage (EGBD)
    The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent.
  • Procedure: Percutaneous cholecystostomy (PC)
    Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag.
Study Arms  ICMJE
  • Active Comparator: EUS-guided gallbladder drainage
    Intervention: Procedure: EUS-guided gallbladder drainage (EGBD)
  • Active Comparator: Percutaneous cholecystomy
    Intervention: Procedure: Percutaneous cholecystostomy (PC)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 6, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Japan,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02212717
Other Study ID Numbers  ICMJE CREC-2014.301-T
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony Teoh, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE
  • American Society for Gastrointestinal Endoscopy
  • Tokyo Medical University
  • Kinki University
  • University of Barcelona
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP