Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

Study Overview
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Brief Summary
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Comparison of ENGBD and PTGBD methods on clinical outcomes and the difficulty of cholecystectomy in later stage in patients with acute suppurative cholecystitis.

Detailed Description
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Laparoscopic cholecystectomy was the standard surgical method for acute cholecystitis unless difficulty in resection due to acute inflammation, no improvement after supportive therapy, or early inability to tolerate cholecystectomy. In this setting, gallbladder drainage was needed. Percutaneous transhepatic gallbladder drainage (PTGBD)was used as a first-line mitigation method, whose restrictions are contraindications and strong pain caused by puncture. Endoscopic technique based on endoscopic retrograde cholangiopancreatography (ERCP) had been made another alternative management for drainage. Endoscopic drainage expanded the indications for drainage without reducing the technical success rate and clinical remission rate, especially less uncomfortable, which greatly improved the quality of life for patients. Unfortunately, because of the difficult procedures and long learning curve, endoscopic gallbladder drainage can only be performed in some large endoscopic centers. Despite a few prospective comparison of PTGBD and endoscopic ultrasound EUS drainage studies so far, there is no prospective study comparing endoscopic naso-gallbladder drainage （ENGBD） and PTGBD, especially in its impacts while cholecystectomy. This study aim to observe clinical effects of ENGBD and PTGBD during the all stage of peri-cholecystectomy.

Official Title
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Comparison of Clinical Efficacy Between ENGBD and PTGBD in Acute Suppurative Cholecystitis: a Single-center, Prospective Randomized Trial

Conditions
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Success Rate

Intervention / Treatment
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* Procedure: Endoscopic naso-gallbladder drainage
* Procedure: Percutaneous gallbladder drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute suppurative cholecystitis Who can not tolerate or unsuitable for cholecystectomy Exclusion Criteria: Unwillingness or inability to consent for the study Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs Bile duct stones Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock Any malignant Pregnant women or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic naso-gallbladder drainage<br>After selective bile duct cannulation, a 0.025- or 0.035-inch guidewire is advanced into the cystic duct and subsequently into the gallbladder. A 5F naso- Pancreas catheter was inserted into the gallbladder for ENGBD. | Procedure: Endoscopic naso-gallbladder drainage<br>* Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.<br>|
| Active Comparator: Percutaneous gallbladder drainage<br>Ultrasound guided，an 18-gauge needle is inserted into the gallbladder，0.035 inch guidewire is coiled into the gallbladder and 9Fr dilator expands the skin,then 8Fr-20cm catheter is placed. | Procedure: Percutaneous gallbladder drainage<br>* Percutaneous transhepatic technique insert drainage tube into gallbladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain remission（visual-analogue scale） | Pain assessment would be performed using the visual-analogue scale after procedures. Draw a 10 cm line on a piece of paper, mark one end of the line with the nubmer 0, indicating no pain; the other end with 10, indicating severe pain; the middle part indicates different degrees of pain. While assesing the pain scale, make sure the patient can not see the numbers on the paper, and let them mark the position according to their feelings about the pain. And the physician will have a score based on the mark. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gallbladder drainage success rate | Bile juice outflow more than 50ml a day | 3 months | 
| Migration | Number of participants with tube dislocation from gallbladder | 3 months | 
| Hemorrhage | Number of participants with bleeding which was defined as hemoglobin deceased, or required transfusion or additional intervention | 3 months | 
| Perforation | Number of participants whose CT scan shows retroperitoneal or gallbladder space fluid or gas | 3 months | 
| Bile leak | Number of participants with bile juice leak into abdomen | 3 months | 
| Number of participants with Pancreatitis | Was defined as typical pain, Serum amylase at least three times than normal after EPCP | 3 months | 
| Cholecystectomy duration | Time of laparoscopic cholecystectomy | 3 months | 
| Hemorrhage during cholecystectomy | The amount of bleeding | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, PTGBD, ENGBD, Gallbladder drainage, Cholecystitis