Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

Not Applicable

Completed

• Conditions: Cholecystitis
• Interventions: Procedure: EUS-guided gallbladder drainage; Procedure: percutaneous transhepatic gallbladder drainage

• Registration Number: NCT01146743
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2010-12
• Status Verified: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-16
• Last Update Posted: 2011-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-guided	EUS-guided gallbladder drainage	EUS-guided gallbladder drainage in acute cholecystitis with high risk patients
percutaneous transhepatic	percutaneous transhepatic gallbladder drainage	percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients

Primary Outcome Measures

Name	Time	Method
Clinical response rate	Within 72 hours from procedure	Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.

Secondary Outcome Measures

Name	Time	Method
Complication rate	Complications during the procedure or within 1 weeks	Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.
Conversion rate	During laparoscopic cholectstectomy	Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of