Post-ERCP cholecystitis
Conditions
Interventions
Experimental Group:Based on routine treatment for acute cholecystitis, take Danshu capsules (specification 0.45g), 2 capsules 3 times a day orally, continuously for 7 days.
Control Group:Based on routine treatment for acute cholecystitis, take Placebo capsules, 2 capsules 3 times a day orally, continuously for 7 days.
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for PEC; 2. Age 18-80 years old, gender is not limited; 3. Sign the informed consent form for clinical trials. Among them, the diagnostic criteria for PEC refer to the 2018 revised Tokyo Guidelines for Acute Cholecystitis Meets the following characteristics: (1) After ERCP, there were signs of inflammation in the right upper quadrant (such as Murphy's sign, right upper quadrant tenderness, etc.), systemic inflammatory reactions (fever, elevated C-reactive protein and white blood cells, etc.), and typical imaging manifestations of acute cholecystitis. (2) There were no clinical manifestations and imaging findings of cholecystitis before ERCP surgery.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to penicillin, cephalosporins and bilishu capsules; 2. Combined with severe heart, liver and kidney dysfunction; 3. Pregnant or lactating women; 4. Combined with autoimmune diseases; 5. Presence of acute pancreatitis or antibiotic use before operation; 6. Severe biliary obstruction after ERCP; 7. Diagnosis of acute purulent cholecystitis, purulent cholangitis, acute gangrenous cholecystitis, gallbladder perforation complicated by peritonitis, perigallbladder abscess and other serious infections after ERCP; 8. Patients with mental disorders; 9. Preoperative use of proprietary Chinese medicines with similar effects or similar ingredients in this study; 10. Combined with malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall effective rate of PEC after 7 days of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptom remission rate after 7 days of treatment;Serological indicators improvement rate after 7 days of treatment;Abdominal ultrasound indicated the improvement rate of cholecystitis after 7 days of treatment;The incidence of adverse drug reactions within 7 days of treatment;Proportion of patients requiring surgery or gallbladder puncture and drainage within 7 days of treatment; | — |
Countries
China
Contacts
Public ContactLiang Zhu
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University
Outcome results
None listed