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

NCT01146743 | Completed

• 1 other identifier: EUS_GB1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis

Keywords

EUS-guided transmural cholecystostomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Complication rate

  Complications during the procedure or within 1 weeks

• Conversion rate

  During laparoscopic cholectstectomy

Study Arms (2)

EUS-guided

ACTIVE COMPARATOR

EUS-guided gallbladder drainage in acute cholecystitis with high risk patients

Procedure: EUS-guided gallbladder drainage

percutaneous transhepatic

ACTIVE COMPARATOR

percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients

Procedure: percutaneous transhepatic gallbladder drainage

Interventions

EUS-guided gallbladder drainage PROCEDURE

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.

Also known as: EUS-guided transmural drainage

EUS-guided

percutaneous transhepatic gallbladder drainage PROCEDURE

Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.

Also known as: percutaneous cholecystostomy

percutaneous transhepatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 17767933 BACKGROUND

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• SangSoo Lee, M.D.

  Asan Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 17, 2011

Record last verified: 2011-03

Locations

KR (1)