Biliary Obstructive Disease Such as CholedocholithiasisNCT02958059
Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
A study testing Pacetin® (cefoxitin) in people with Biliary Obstructive Disease Such as Choledocholithiasis and Benign Biliary Stricture, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Obstructive Disease Such as Choledocholithiasis, Benign Biliary Stricture, Peri-ampullary Cancer
- What is being tested?
- Pacetin® (cefoxitin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2016to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biliary obstructive disease (Benign or Malignant)
- 19 year-old and older than 19 year-old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei university of medical center
Seoul, 03722
Seung Min Bang, MD, +82 2 2228 1995, BANG7028@yuhs.ac
About this study
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
- Biliary Obstructive Disease Such as Choledocholithiasis, Benign Biliary Stricture, Peri-ampullary Cancer, Bile Duct Cancer Resectable, Klatskin Tumor
- Being tested
- Pacetin® (cefoxitin), Placebo
- Keywords
- ERCP, prophylaxis, antibiotics, infection, cholangitis
- Medical subject headings
- Klatskin Tumor, Infections, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacetin® (cefoxitin)Biological
Also called Antibiotic prophylaxis
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.
PlaceboBiological
Also called normal saline
10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The intervention group Receives: Biological: Pacetin® (cefoxitin) |
| Comparator | Placebo comparator | The comparator group Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complication that related with infection.
Measured: within 10 days
Secondary outcomes (2)
Rate of post-ERCP cholangitis
Measured: within 10 days
Grade of post-ERCP infectious complication
Grade of post-ERCP infectious complications based upon a consensus definition Mild : >38°C for 24-48 hr / Moderate : Febrile or septic illness requiring more than 3 days of hospital treatment or endoscopic or percutaneous intervention / Severe : Septic shock or surgery
Measured: within 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start1 Dec 2016
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Obstructive Disease Such as CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958059
- Sponsor's protocol ID
- 4-2015-0596
- Status last verified
- Jan 2019
- First submitted
- 1 Nov 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37713527
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
- ClinicalTrials.gov ID
- NCT02958059
- Acronym / sponsor ID
- 4-2015-0596
- Conditions
- Biliary Obstructive Disease Such as Choledocholithiasis, Benign Biliary Stricture, Peri-ampullary Cancer, Bile Duct Cancer Resectable, Klatskin Tumor
- Keywords
- ERCP, prophylaxis, antibiotics, infection, cholangitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Pacetin® (cefoxitin)The intervention group |
| Comparator | Placebo comparator | Biological: PlaceboThe comparator group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with biliary obstructive disease (Benign or Malignant)
- 19 year-old and older than 19 year-old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacetin® (cefoxitin)Also: Antibiotic prophylaxis1~2g 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. | Biological | Treatment |
| PlaceboAlso: normal saline10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye. | Biological | Comparator |
Primary outcome
Rate of complication that related with infection.
Time frame: within 10 days
2 secondary outcomes
Rate of post-ERCP cholangitis
Time frame: within 10 days
Grade of post-ERCP infectious complication
Time frame: within 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 37713527Leem 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacetin® (cefoxitin) in people with Biliary Obstructive Disease Such as Choledocholithiasis and Benign Biliary Stricture, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Min Bang, MD (+82-02-2228-1995, BANG7028@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complication that related with infection. (time frame: within 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.