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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholecystitis

Intervention / Treatment
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* Procedure: EUS-guided gallbladder drainage
* Procedure: percutaneous transhepatic gallbladder drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-guided<br>EUS-guided gallbladder drainage in acute cholecystitis with high risk patients | Procedure: EUS-guided gallbladder drainage<br>* 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.<br>* Other names: EUS-guided transmural drainage;|
| Active Comparator: percutaneous transhepatic<br>percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients | Procedure: percutaneous transhepatic gallbladder drainage<br>* Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.<br>* Other names: percutaneous cholecystostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Conversion rate | Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy. | During laparoscopic cholectstectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS-guided transmural cholecystostomy