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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

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.


Condition or disease Intervention/treatment Phase
Acute Cholecystitis Procedure: EUS-guided gallbladder drainage (EGBD) Procedure: Percutaneous cholecystostomy (PC) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.
Study Start Date : August 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EUS-guided gallbladder drainage 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.

Active Comparator: Percutaneous cholecystomy 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.




Primary Outcome Measures :
  1. Overall morbidities [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Stone clearance rates [ Time Frame: 1 years ]
    The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography

  5. 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.

  6. Reintervention rate [ Time Frame: 1 year ]
    The number of patients requiring biliary related re-interventions within 1 year

  7. Re-admission rate [ Time Frame: 1 year ]
    The number of patients requiring hospital re-admissions due to biliary related events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212717


Locations
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China, Hong Kong
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Japan
Kinki University Hospital
Osaka, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Spain
University Hospital Rio Hortega
Barcelona, Spain
Sponsors and Collaborators
Chinese University of Hong Kong
American Society for Gastrointestinal Endoscopy
Tokyo Medical University
Kinki University
University of Barcelona

Publications:
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Responsible Party: Anthony Teoh, Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02212717     History of Changes
Other Study ID Numbers: CREC-2014.301-T
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Keywords provided by Anthony Teoh, Chinese University of Hong Kong:
Acute cholecystitis
EUS-guided gallbladder drainage
Percutaneous cholecystostomy
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases