EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.
NCT ID: NCT04197908
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-11-29
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EUS-guided gallbladder drainage (EGBD)
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.
EUS-guided gallbladder drainage (EGBD)
As listed in the arms description
Interventions
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EUS-guided gallbladder drainage (EGBD)
As listed in the arms description
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Anthony Teoh
Honorary Associate Professor
Principal Investigators
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Anthony Teoh
Role: PRINCIPAL_INVESTIGATOR
CUHK
Locations
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Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Countries
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Other Identifiers
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CREC-2016.609
Identifier Type: -
Identifier Source: org_study_id
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