Back to resultsEUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study. (EGDB)
Primary Purpose
Acute Cholecystitis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-guided gallbladder drainage (EGBD)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis focused on measuring Acute cholecystitis, EUS-guided gallbladder drainage, Laparoscopic cholecystectomy, gallbladder polyp, gallstone
Eligibility Criteria
Inclusion Criteria:
Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.
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)
- Patients with duodenal obstruction
- 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: international normalised ratio (INR) > 1.5 and/or platelets < 50.000/mm3
- Previous drainage of the gallbladder
Sites / Locations
- Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS-guided gallbladder drainage (EGBD)
Arm Description
The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean.
Outcomes
Primary Outcome Measures
Clinical success rate
Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%
Secondary Outcome Measures
Technical success rate
Defined as successful placement of a metal stent between the gallbladder and the duodenum or the stomach
30-day adverse events rate
Adverse events would be graded according to the lexicon of endoscopic adverse events
Stone or polyp recurrences
An ultrasonography of the abdomen would also be arranged yearly to check for recurrence of stones or polyps.
Quality of life scores: Gastrointestinal quality of life index
Gastrointestinal quality of life index
Mortality rate
Death from any cause
Reintervention rate
The number of patients requiring biliary related re-interventions within 3 years.
Full Information
NCT ID
NCT04197908
First Posted
December 6, 2019
Last Updated
February 6, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04197908
Brief Title
EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.
Acronym
EGDB
Official Title
Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 29, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.
Detailed Description
The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.
The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.
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, Laparoscopic cholecystectomy, gallbladder polyp, gallstone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-guided gallbladder drainage (EGBD)
Arm Type
Experimental
Arm Description
The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean.
Intervention Type
Device
Intervention Name(s)
EUS-guided gallbladder drainage (EGBD)
Intervention Description
As listed in the arms description
Primary Outcome Measure Information:
Title
Clinical success rate
Description
Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Defined as successful placement of a metal stent between the gallbladder and the duodenum or the stomach
Time Frame
30 days
Title
30-day adverse events rate
Description
Adverse events would be graded according to the lexicon of endoscopic adverse events
Time Frame
30 days
Title
Stone or polyp recurrences
Description
An ultrasonography of the abdomen would also be arranged yearly to check for recurrence of stones or polyps.
Time Frame
3 years
Title
Quality of life scores: Gastrointestinal quality of life index
Description
Gastrointestinal quality of life index
Time Frame
3 years
Title
Mortality rate
Description
Death from any cause
Time Frame
3 years
Title
Reintervention rate
Description
The number of patients requiring biliary related re-interventions within 3 years.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.
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)
Patients with duodenal obstruction
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: international normalised ratio (INR) > 1.5 and/or platelets < 50.000/mm3
Previous drainage of the gallbladder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Teoh
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.
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