Comparison of ENGBD and PTGBD methods on clinical outcomes and the difficulty of cholecystectomy in later stage in patients with acute suppurative cholecystitis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.
Percutaneous transhepatic technique insert drainage tube into gallbladder
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, China
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.
Time frame: 3 weeks
Gallbladder drainage success rate
Bile juice outflow more than 50ml a day
Time frame: 3 months
Migration
Number of participants with tube dislocation from gallbladder
Time frame: 3 months
Hemorrhage
Number of participants with bleeding which was defined as hemoglobin deceased, or required transfusion or additional intervention
Time frame: 3 months
Perforation
Number of participants whose CT scan shows retroperitoneal or gallbladder space fluid or gas
Time frame: 3 months
Bile leak
Number of participants with bile juice leak into abdomen
Time frame: 3 months
Number of participants with Pancreatitis
Was defined as typical pain, Serum amylase at least three times than normal after EPCP
Time frame: 3 months
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Cholecystectomy duration
Time of laparoscopic cholecystectomy
Time frame: 3 months
Hemorrhage during cholecystectomy
The amount of bleeding
Time frame: 3 months