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

Primary Purpose

Acute Cholecystitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EUS-guided gallbladder drainage (EGBD)
Percutaneous cholecystostomy (PC)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis focused on measuring Acute cholecystitis, EUS-guided gallbladder drainage, Percutaneous cholecystostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese University of Hong Kong
  • Kinki University Hospital
  • Tokyo Medical University Hospital
  • University Hospital Rio Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS-guided gallbladder drainage

Percutaneous cholecystomy

Arm Description

Outcomes

Primary Outcome Measures

Overall morbidities

Secondary Outcome Measures

Technical success
Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.
Pain scores
Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
Analgesic requirements
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
The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography
Clinical success
Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.
Reintervention rate
The number of patients requiring biliary related re-interventions within 1 year
Re-admission rate
The number of patients requiring hospital re-admissions due to biliary related events

Full Information

First Posted
August 5, 2014
Last Updated
July 29, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
American Society for Gastrointestinal Endoscopy, Tokyo Medical University, Kinki University, University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT02212717
Brief Title
A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.
Acronym
DRAC
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
American Society for Gastrointestinal Endoscopy, Tokyo Medical University, Kinki University, University of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
Acute cholecystitis, EUS-guided gallbladder drainage, Percutaneous cholecystostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-guided gallbladder drainage
Arm Type
Active Comparator
Arm Title
Percutaneous cholecystomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
EUS-guided gallbladder drainage (EGBD)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous cholecystostomy (PC)
Intervention Description
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 Measure Information:
Title
Overall morbidities
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.
Time Frame
30 days
Title
Pain scores
Description
Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
Time Frame
7 days
Title
Analgesic requirements
Description
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.
Time Frame
7 days
Title
Stone clearance rates
Description
The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography
Time Frame
1 years
Title
Clinical success
Description
Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.
Time Frame
30 days
Title
Reintervention rate
Description
The number of patients requiring biliary related re-interventions within 1 year
Time Frame
1 year
Title
Re-admission rate
Description
The number of patients requiring hospital re-admissions due to biliary related events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
Facility Name
Kinki University Hospital
City
Osaka
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
Country
Japan
Facility Name
University Hospital Rio Hortega
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23206813
Citation
de la Serna-Higuera C, Perez-Miranda M, Gil-Simon P, Ruiz-Zorrilla R, Diez-Redondo P, Alcaide N, Sancho-del Val L, Nunez-Rodriguez H. EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent. Gastrointest Endosc. 2013 Feb;77(2):303-8. doi: 10.1016/j.gie.2012.09.021. Epub 2012 Dec 1. No abstract available.
Results Reference
background
PubMed Identifier
22301347
Citation
Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc. 2012 Apr;75(4):870-6. doi: 10.1016/j.gie.2011.10.020. Epub 2012 Jan 31.
Results Reference
background
PubMed Identifier
24830582
Citation
Teoh AY, Binmoeller KF, Lau JY. Single-step EUS-guided puncture and delivery of a lumen-apposing stent for gallbladder drainage using a novel cautery-tipped stent delivery system. Gastrointest Endosc. 2014 Dec;80(6):1171. doi: 10.1016/j.gie.2014.03.038. Epub 2014 May 13. No abstract available.
Results Reference
background
PubMed Identifier
32165407
Citation
Teoh AYB, Kitano M, Itoi T, Perez-Miranda M, Ogura T, Chan SM, Serna-Higuera C, Omoto S, Torres-Yuste R, Tsuichiya T, Wong KT, Leung CH, Chiu PWY, Ng EKW, Lau JYW. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12.
Results Reference
derived

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

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