NCT02958059

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

November 1, 2016

Last Update Submit

January 15, 2019

Conditions

Biliary Obstructive Disease Such as CholedocholithiasisBenign Biliary StricturePeri-ampullary CancerBile Duct Cancer ResectableKlatskin Tumor

Keywords

ERCPprophylaxisantibioticsinfectioncholangitis

Outcome Measures

Primary Outcomes (1)

  • Rate of complication that related with infection.

    within 10 days

Secondary Outcomes (2)

  • Rate of post-ERCP cholangitis

    within 10 days

  • Grade of post-ERCP infectious complication

    within 10 days

Study Arms (2)

Treatment

EXPERIMENTAL

The intervention group

Biological: Pacetin® (cefoxitin)

Comparator

PLACEBO COMPARATOR

The comparator group

Biological: Placebo

Interventions

Pacetin® (cefoxitin)BIOLOGICAL

1\~2g of Cefoxitin (2nd generation cephalosporin) is administered to patients 30 minutes Before ERCP procedure. Cefoxitin is mixed with 10ml of normal saline. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.

Also known as: Antibiotic prophylaxis
Treatment
PlaceboBIOLOGICAL

10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.

Also known as: normal saline
Comparator

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with biliary obstructive disease (Benign or Malignant)
  • year-old and older than 19 year-old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei university of medical center

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

  • Leem 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: 37713527DERIVED

MeSH Terms

Conditions

Klatskin TumorInfectionsCholangitis

Interventions

CefoxitinAntibiotic ProphylaxisSaline Solution

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CephamycinsCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChemopreventionDrug TherapyTherapeuticsPremedicationCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Seung Min Bang, MD

CONTACT

+82-02-2228-1995BANG7028@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 8, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)