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

Cholecystitis Clinical Trial

Official title:

Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146743
• Other study ID #: EUS_GB1
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: March 16, 2011
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Lee SS, Park do H, 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. Epub 2007 Sep 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate	Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.	Within 72 hours from procedure	Yes
Secondary	Complication rate	Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.	Complications during the procedure or within 1 weeks	Yes
Secondary	Conversion rate	Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.	During laparoscopic cholectstectomy	Yes