Brief Title
EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.
Official Title
Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study
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.
Study Type
Interventional
Primary Outcome
Clinical success rate
Secondary Outcome
Technical success rate
Condition
Acute Cholecystitis
Intervention
EUS-guided gallbladder drainage (EGBD)
Study Arms / Comparison Groups
EUS-guided gallbladder drainage (EGBD)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
November 29, 2019
Completion Date
June 30, 2024
Primary Completion Date
June 30, 2021
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Anthony Teoh, 35052956, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04197908
Organization ID
CREC-2016.609
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Study Sponsor
Anthony Teoh, Principal Investigator, CUHK
Verification Date
February 2020