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NCT Number: NCT01146743

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

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.

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: EUS-guided transmural drainage

percutaneous transhepatic gallbladder drainage

Procedure

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

Other names: percutaneous cholecystostomy

Primary outcomes

  1. Clinical response rate

    Time frame: 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 outcomes

  1. Complication rate

    Time frame: 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.

  2. Conversion rate

    Time frame: During laparoscopic cholectstectomy

    Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Mar 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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