EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.
EGDB
Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study
1 other identifier
interventional
30
1 country
1
Brief Summary
To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2019
CompletedFirst Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMarch 20, 2026
March 1, 2026
4.6 years
December 6, 2019
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical success rate
Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%
30 days
Secondary Outcomes (6)
Technical success rate
30 days
30-day adverse events rate
30 days
Stone or polyp recurrences
3 years
Quality of life scores: Gastrointestinal quality of life index
3 years
Mortality rate
3 years
- +1 more secondary outcomes
Study Arms (1)
EUS-guided gallbladder drainage (EGBD)
EXPERIMENTALThe 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.
Interventions
As listed in the arms description
Eligibility Criteria
You may qualify if:
- Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Teoh
CUHK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Associate Professor
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 13, 2019
Study Start
November 29, 2019
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
March 20, 2026
Record last verified: 2026-03