Clinical trial · Interventional
Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality. Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected. In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Biliary Stricture | — | UNRESOLVED | — |
| Bile Duct Cancer Resectable | — | UNRESOLVED | — |
| Biliary Obstructive Disease Such as Choledocholithiasis | — | UNRESOLVED | — |
| Klatskin Tumor | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
| Peri-ampullary Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pacetin® (cefoxitin) | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- The intervention group
- interventionNames
- Biological: Pacetin® (cefoxitin)
- type
- PLACEBO_COMPARATOR
- label
- Comparator
- description
- The comparator group
- interventionNames
- Biological: Placebo
Primary outcomes (1)
- measure
- Rate of complication that related with infection.
- timeFrame
- within 10 days
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with biliary obstructive disease (Benign or Malignant) * 19 year-old and older than 19 year-old Exclusion Criteria: * Younger than 19 year-old * Patients with leukocytosis (WBC ≥ 11,000/mm3) * Body temperature ≥ 38 °C within 72 hours before ERCP * History of antibiotics administration due to cholangitis, cholecystitis or sepsis within 72 hours before ERCP * Pregnancy women * Patients with allergy to beta-lactam
References
Publications (1)
- DERIVEDLeem G, Sung MJ, Park JH, Kim SJ, Jo JH, Lee HS, Ku NS, Park JY, Bang S, Park SW, Song SY, Chung MJ. Randomized Trial of Prophylactic Antibiotics for Endoscopic Retrograde Cholangiopancreatography in Patients With Biliary Obstruction. Am J Gastroenterol. 2024 Jan 1;119(1):183-190. doi: 10.14309/ajg.0000000000002495. Epub 2023 Sep 15. PMID 37713527