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Does prophylactic antibiotics reduce infectious complications post endoscopic retrograde cholangio pancreatography in common bile duct stones patients: a clinical trial?

Prophylactic antibiotics reduce infectious complications post endoscopic retrograde cholangio pancreatography in common bile duct stones patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32773697
Enrollment
240
Registered
2025-05-01
Start date
2022-12-31
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of infectious complications post endoscopic retrograde cholangio pancreatography in common bile duct stones patients Surgery

Interventions

The study plans to enroll approximately 240 patients with common bile duct stones without signs of cholangitis at the time of hospital admission. All patients have an indication for ERCP stone extract

Sponsors

108 Military Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with common bile duct stones are diagnosed by abdominal ultrasound, endoscopic ultrasound, CT scan, or abdominal MRI. 2. No signs of cholangitis at the time of admission, defined by the following criteria: 2.1. Non fever (temperature < 37°C) 2.2. White blood cell count between 4 G/L and 10 G/L 2.3. Good general condition, classified as ASA Physical Status I or II

Exclusion criteria

Exclusion criteria: 1. Patients with severe coagulopathy (INR > 1.5 or platelet count < 50 G/L) 2. Patients with severe systemic illnesses, such as unstable myocardial infarction, respiratory failure, or circulatory failure 3. Patients with duodenal perforation or failed ERCP due to inability to access the papilla 4. Patients with active infections in other organ systems requiring antibiotic therapy 5. Patients have received any systemic antibiotics within 48 hours prior to the ERCP procedure 6. Patients are allergic to antibiotics used in the study

Design outcomes

Primary

MeasureTime frame
Infectious complications measured through examining the patients and assessing clinical symptoms such as fever, abdominal pain, and jaundice at ...

Secondary

MeasureTime frame
1. Complete blood count (CBC) is measured using a CBC test at hospital admission and 24–48 hours after the ERCP procedure 2. GOT is measured using a GOT test at hospital admission and 24–48 hours after the ERCP procedure 3. GPT is measured using a GPT test at hospital admission and 24–48 hours after the ERCP procedure 4. GGT is measured using a GGT test at hospital admission and 24–48 hours after the ERCP procedure 5. ALP is measured using an ALP test at hospital admission and 24–48 hours after the ERCP procedure 6. Total bilirubin is measured using a total bilirubin test at hospital admission and 24–48 hours after the ERCP procedure 7. Direct bilirubin is measured using a direct bilirubin test at hospital admission and 24–48 hours after the ERCP procedure 8. Amylase is measured using an amylase test at hospital admission and 24–48 hours after the ERCP procedure 9. Lipase is measured using a lipase test at hospital admission and 24–48 hours after the ERCP procedure 10. CRP is measured using a CRP test at hospital admission and 24–48 hours after the ERCP procedure 11. Procalcitonin is measured using a procalcitonin test at hospital admission and 24–48 hours after the ERCP procedure Additional tests are performed if abnormal signs or changes are observed until clinical condition stabilizes and discharge from the hospital

Countries

Viet Nam

Contacts

Public ContactThanh;Tung Tran Van;Nguyen Lam

;

bvtuqd108@benhvien108.vn;nguyenlamtung108@gmail.com+84 977157219;+84 987481976

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026