Does prophylactic antibiotics reduce infectious complications post endoscopic retrograde cholangio pancreatography in common bile duct stones patients: a clinical trial?
| ISRCTN | ISRCTN32773697 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32773697 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 337/QD-VNC |
| Sponsor | 108 Military Central Hospital |
| Funder | 108 Military Central Hospital |
- Submission date
- 22/04/2025
- Registration date
- 01/05/2025
- Last edited
- 01/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used to diagnose and treat problems in the bile and pancreatic ducts. One common issue it addresses is stones in the common bile duct. However, ERCP can be risky and may lead to complications like pancreatitis, bleeding, perforation, and infections. Infections can occur in 5% to 18% of cases and are responsible for about 7.8% of deaths related to ERCP complications. To reduce infection risks, some methods have been suggested, such as using fewer contrast injections, lowering bile duct pressure, ensuring complete drainage, and using preventive antibiotics. However, the use of preventive antibiotics is debated because it can lead to antibiotic resistance, which is a growing global problem. Major medical societies recommend antibiotics only in specific cases, but the evidence supporting this is not strong. This study aims to find out if using preventive antibiotics can lower infection rates after ERCP in patients with bile duct stones.
Who can participate?
Adults over 18 years old who:
Have common bile duct stones diagnosed by ultrasound, CT scan, or MRI.
Show no signs of cholangitis (no fever and normal white blood cell count).
Are in good general health (classified as ASA Physical Status I or II).
What does the study involve?
Participants will be patients with bile duct stones who need ERCP but do not have cholangitis. They will be randomly assigned to one of three groups:
Prophylactic Antibiotic Group: Will receive Amikacin (an antibiotic) before the ERCP procedure.
Full-dose Antibiotic Group: Will receive Amikacin and a third-generation cephalosporin antibiotic from before the ERCP until hospital discharge.
Control Group: Will not receive antibiotics, only normal saline.
After ERCP, patients will be monitored for signs of infection through symptoms and lab tests.
What are the possible benefits and risks of participating?
This study may help promote the appropriate use of antibiotics during ERCP in patients with common bile duct stones. As a result, it could reduce antibiotic resistance in the community, as well as lower healthcare costs and shorten hospital stays.
The main risk of this study is the possibility of allergic reactions in the group receiving antibiotics. In the group not receiving antibiotics, there may be a higher risk of post-ERCP infectious complications.
Where is the study run from?
The study is being run at the 108 Military Central Hospital in Hanoi, Vietnam.
When is the study starting and how long is it expected to run for?
December 2022 to December 2025
Who is funding the study?
108 Military Central Hospital, Hanoi, Vietnam.
Who is the main contact?
1. Prof. Nguyen Lam Tung
nguyenlamtung108@gmail.com
2. Dr. Tran Van Thanh
vanthanh260290@gmail.com
Contact information
Public, Scientific, Principal investigator
No. 1 Tran Hung Dao, Bach Dang Ward, Hai Ba Trung District
Hanoi
100000
Viet Nam
 ORCID ID |
0009-0007-1107-4354 |
|---|---|
| Phone | +84 977157219 |
| bvtuqd108@benhvien108.vn |
Public, Scientific, Principal investigator
No. 1 Tran Hung Dao, Bach Dang Ward, Hai Ba Trung District
Hanoi
100000
Viet Nam
| Phone | +84 987481976 |
|---|---|
| nguyenlamtung108@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional open-label randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 47214 PIS (English).pdf |
| Scientific title | Prophylactic antibiotics reduce infectious complications post endoscopic retrograde cholangio pancreatography in common bile duct stones patients |
| Study objectives | Prophylactic antibiotics reduce the infectious complications post Endoscopic Retrograde Cholangio Pancreatography intervention in common bile duct stones patients. |
| Ethics approval(s) |
Approved 31/12/2022, Ethics Committee of the 108 Military Central Hospital (No. 1 Tran Hung Dao, Bach Dang Ward, Hai Ba Trung District, Hanoi, 100000, Viet Nam; +84 1900986869; bvtuqd108@benhvien108.vn), ref: 6893 |
| Health condition(s) or problem(s) studied | Prevention of infectious complications post endoscopic retrograde cholangio pancreatography in common bile duct stones patients |
| Intervention | 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 extraction and randomly assigned to one of three study groups. • Prophylactic Antibiotic Group + Medication: Amikacin + Administration: Amikacin at a dose of 15 mg/kg, diluted in 0.9% NaCl to a total volume of 100 mL, administered via intravenous infusion over 60 minutes + Timing: Administered 60 minutes before ERCP procedure. For patients with renal impairment, the Amikacin dose will be adjusted based on glomerular filtration rate (GFR). + Other Names: Antibiotic prophylaxis • Full-dose Antibiotic Group + Medications: Amikacin + Third-generation Cephalosporine + Administration: Amikacin at 15 mg/kg/day in combination with Cefoperazone 2 g twice daily, administered by slow intravenous injection every 12 hours + Timing: From before the ERCP procedure until hospital discharge, typically lasting 4–7 days. • Control Group: No Antibiotics Group + Medication: normal saline + Administration: No antibiotics administered. Patients will receive an intravenous infusion of normal saline on the day of the procedure. Participants were randomly assigned to one of the three groups using a simple randomization method in which the remainder of their record number divided by 3 determined the group allocation |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Infectious complications measured through examining the patients and assessing clinical symptoms such as fever, abdominal pain, and jaundice at ... |
| Key secondary outcome measure(s) |
1. Complete blood count (CBC) is measured using a CBC test at hospital admission and 24–48 hours after the ERCP procedure |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 31/12/2022 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Hanoi
100000
Viet Nam
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | - The datasets generated during and/or analysed during the current study will be available upon request from (Thanh Tran Van, vanthanh260290@gmail.com) - The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | English | 01/05/2025 | No | Yes | |
| Participant information sheet | Vietnamese | 01/05/2025 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 01/05/2025 | No | No |
Additional files
- 47214 PIS (English).pdf
- English
- 47214 PIS (Vietnamese).pdf
- Vietnamese
- 47214 Study Protocol.pdf
- Protocol file
Editorial Notes
22/04/2025: Trial's existence confirmed by Ethics Committee of the 108 Military Central Hospital.
