Back to resultsProspective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
Primary Purpose
Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EUS-guided gallbladder drainage
percutaneous transhepatic gallbladder drainage
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring EUS-guided transmural cholecystostomy
Eligibility Criteria
Inclusion Criteria:
- high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)
Exclusion Criteria:
- Age below 18 years
- 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EUS-guided
percutaneous transhepatic
Arm Description
EUS-guided gallbladder drainage in acute cholecystitis with high risk patients
percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients
Outcomes
Primary Outcome Measures
Clinical response rate
Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.
Secondary Outcome Measures
Complication rate
Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.
Conversion rate
Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01146743
Brief Title
Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
Official Title
Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.
Detailed Description
The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.
The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
Keywords
EUS-guided transmural cholecystostomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EUS-guided
Arm Type
Active Comparator
Arm Description
EUS-guided gallbladder drainage in acute cholecystitis with high risk patients
Arm Title
percutaneous transhepatic
Arm Type
Active Comparator
Arm Description
percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients
Intervention Type
Procedure
Intervention Name(s)
EUS-guided gallbladder drainage
Other Intervention Name(s)
EUS-guided transmural drainage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
percutaneous transhepatic gallbladder drainage
Other Intervention Name(s)
percutaneous cholecystostomy
Intervention Description
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Primary Outcome Measure Information:
Title
Clinical response rate
Description
Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.
Time Frame
Within 72 hours from procedure
Secondary Outcome Measure Information:
Title
Complication rate
Description
Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.
Time Frame
Complications during the procedure or within 1 weeks
Title
Conversion rate
Description
Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.
Time Frame
During laparoscopic cholectstectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)
Exclusion Criteria:
Age below 18 years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SangSoo Lee, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
17767933
Citation
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.
Results Reference
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Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
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