Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Success Rate

Treatments: Procedure: Percutaneous gallbladder drainage; Procedure: Endoscopic naso-gallbladder drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT03701464

ENGBD in acute cholecystitis

Details and patient eligibility

About

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

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Endoscopic naso-gallbladder drainage

Experimental group

Description:

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.

Treatment:

Procedure: Endoscopic naso-gallbladder drainage

Percutaneous gallbladder drainage

Active Comparator group

Description:

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.

Treatment:

Procedure: Percutaneous gallbladder drainage