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

July 29, 2019 updated by: Anthony Teoh, Chinese University of Hong Kong

Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Chinese University of Hong Kong
      • Osaka, Japan
        • Kinki University Hospital
      • Tokyo, Japan
        • Tokyo Medical University Hospital
      • Barcelona, Spain
        • University Hospital Rio Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EUS-guided gallbladder drainage
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall morbidities
Time Frame: 1 years
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
7 days
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.
7 days
Stone clearance rates
Time Frame: 1 years
The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography
1 years
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.
30 days
Reintervention rate
Time Frame: 1 year
The number of patients requiring biliary related re-interventions within 1 year
1 year
Re-admission rate
Time Frame: 1 year
The number of patients requiring hospital re-admissions due to biliary related events
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Cholecystitis

Clinical Trials on EUS-guided gallbladder drainage (EGBD)

3
Subscribe