Choledocholithiasis, Recurrence
Conditions
Brief summary
\[objective\] to compare the efficacy of Danshu capsule and ursodeoxycholic acid (UDCA) in preventing recurrence of choledocholithiasis after operation. \[methods\] one hundred and fifty ERCP patients with choledocholithiasis were randomly divided into two groups: Danshu group (n = 75) and UDCA group (n = 75). The Danshu group took 2 Danshu capsules three times a day, and the UDCA group took 250 mg of Ursofalk twice a day. The clinical efficacy, changes of liver function indexes before and after treatment and stone recurrence were compared between the two groups.
Interventions
DRUGoral Danshu capsule
Danshu group oral Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets, Sichuan Jishengtang Pharmaceutical Co., Ltd.)
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Choledocholithiasis was diagnosed by B-ultrasound / CT/MRCP, The patients are generally in good condition, no surgical taboos, and can tolerate general anesthesia and ERCP surgery. 2. Agree to participate in the project research, know the benefits and possible risks of surgery, know the benefits and risks of drugs, and sign an informed consent form.
Exclusion criteria
： 1. patients with cholecystolithiasis, hepatitis B, biliary ascariasis, liver cirrhosis, hemolytic anemia, congenital jaundice and tumor were excluded. 2. Excluding serious primary diseases such as heart, brain, lung, kidney and blood system. 3. Those who are allergic or allergic to drugs in this test are excluded. 4. Pregnancy vibration or nursing women were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence rate | 1 year | abdominal ultrasound or MRCP/CT was used to examine every 3 months after operation for 1 year, and the recurrence was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement rate of liver function index | 3 days, 1 week and 2 weeks | 5ml of fasting elbow venous blood was taken before treatment and 3 days, 1 week and 2 weeks after treatment respectively. The blood samples were centrifuged and the supernatant was taken. Total bilirubin (total bilirubin, TBil), glutamic pyruvic transaminase (Alanine aminotransferase, ALT), glutamic oxaloacetic transaminase (Aspartate aminotransferase, AST) and γ-glutamyl transpeptidase (γ-glutamyl transpeptidase, GGT)) in blood samples were detected by automatic biochemical analyzer. |
Countries
China
Outcome results
None listed