Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
NCT ID: NCT01146743
Last Updated: 2011-03-17
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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COMPLETED
NA
59 participants
INTERVENTIONAL
2010-06-30
2011-03-31
Brief Summary
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Detailed Description
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The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EUS-guided
EUS-guided gallbladder drainage in acute cholecystitis with high risk patients
EUS-guided gallbladder drainage
EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.
percutaneous transhepatic
percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients
percutaneous transhepatic gallbladder drainage
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Interventions
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EUS-guided gallbladder drainage
EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.
percutaneous transhepatic gallbladder drainage
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
* Unstable or unwilling to comply with follow-up
* When a perforated viscus is known or suspected
* Simultaneously participating in another investigational drug or device study
18 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Asan Medical Center
Principal Investigators
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SangSoo Lee, M.D.
Role: STUDY_DIRECTOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Lee SS, Park DH, Hwang CY, Ahn CS, Lee TY, Seo DW, Lee SK, Kim MW. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007 Nov;66(5):1008-12. doi: 10.1016/j.gie.2007.03.1080. Epub 2007 Sep 4.
Other Identifiers
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EUS_GB1
Identifier Type: -
Identifier Source: org_study_id
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