Success Rate
Conditions
Keywords
ERCP, PTGBD, ENGBD, Gallbladder drainage, Cholecystitis
Brief summary
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
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.
Interventions
PROCEDUREEndoscopic naso-gallbladder drainage
Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.
PROCEDUREPercutaneous gallbladder drainage
Percutaneous transhepatic technique insert drainage tube into gallbladder
Sponsors
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain remission（visual-analogue scale） | 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migration | 3 months | Number of participants with tube dislocation from gallbladder |
| Hemorrhage | 3 months | Number of participants with bleeding which was defined as hemoglobin deceased, or required transfusion or additional intervention |
| Perforation | 3 months | Number of participants whose CT scan shows retroperitoneal or gallbladder space fluid or gas |
| Gallbladder drainage success rate | 3 months | Bile juice outflow more than 50ml a day |
| Number of participants with Pancreatitis | 3 months | Was defined as typical pain, Serum amylase at least three times than normal after EPCP |
| Cholecystectomy duration | 3 months | Time of laparoscopic cholecystectomy |
| Hemorrhage during cholecystectomy | 3 months | The amount of bleeding |
| Bile leak | 3 months | Number of participants with bile juice leak into abdomen |
Countries
China
Outcome results
None listed