Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.
The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure.
The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short duration of antibiotic | Active Comparator | group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued |
|
| Standard treatment of antibiotic | Active Comparator | group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short duration of antibiotic | Other | Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The recurrence rate of cholangitis | The number of patients who has recurrence of fever after complete treatment without other sources identified | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of adequacy of drainage | The number of patient with cholangiography at the end of the procedure showed no fill defect in the bile duct. | 24 hours |
| Complication rate | The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nisa Netinatsunton, MD. | NKC Institute of Gastroenterology and Hepatology. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard treatment of antibiotic | Other | Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature. |
|
|
| 4 weeks |
| Mortality rate | The number of patient with death | 4 weeks |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |