Unique ID issued by UMIN | UMIN000054071 |
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Receipt number | R000061735 |
Scientific Title | Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3) |
Date of disclosure of the study information | 2024/04/09 |
Last modified on | 2024/04/05 09:59:08 |
Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3)
BOLT-P3
Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3)
BOLT-P3
Japan |
Acute cholangitis
Hepato-biliary-pancreatic medicine |
Others
NO
The recommended duration of antibiotics for acute cholangitis globally is based largely on retrospective studies. In recent years, there has been an increase in retrospective studies suggesting the possibility of shortening the administration period. Concurrently, research on the emergence of resistant bacteria due to long-term administration and the adverse effects of antibiotics themselves has advanced. Therefore, it is presumed that short-course treatments are not inferior to current standard treatments based on evidence could lead to a reduction in the emergence of resistant bacteria, adverse antibiotic events, hospital stay durations, and medical costs.
Efficacy
Confirmatory
Phase III
The primary outcome is defined as the rate of cases that achieve clinical cure within 14 days and survive without recurrence.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Medicine |
This study aims to verify that the efficacy of antibiotic treatment for acute cholangitis following biliary drainage in the trial treatment group, lasting 24-72 hours, is not inferior to that in the standard treatment group, which lasts 96-168 hours.
For the trial treatment group (method and type of antibiotic administration):
Antibiotics are principally administered intravenously. The administration period is 24-72 hours after sufficient biliary drainage has been achieved. To clarify the difference from the standard treatment group, the antibiotic administration duration is specifically set to 24-72 hours. Similar to the standard treatment group, following the recommendations of TG18, a choice is made from aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, sulfonamides, and penicillins. The specific choice of medication is not strictly defined but may be altered based on allergies, local protocols, and previous culture results.
For the standard treatment group (method and type of antibiotic administration):
Antibiotics are principally administered intravenously. The administration period is 96-168 hours after sufficient biliary drainage has been achieved. To clearly differentiate from the trial treatment group, the antibiotic administration duration in this study is specifically set to 96-168 hours. Following the recommendations of Tokyo Guideline 2018 (TG18), a choice is made from aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, sulfonamides, and penicillins. The specific choice of medication is not strictly defined but may be altered based on allergies, local protocols, and previous culture results.
18 | years-old | <= |
Not applicable |
Male and Female
Participants must meet all of the following criteria:
1. Disease: Patients diagnosed with AC in accordance with the TG18, regardless of benign or malignant nature. However, for patients with AC due to dysfunction of distal bile duct stents, inclusion is limited to those who have had a stent in place for more than 30 days.
2. Age: 18 years or older.
3. Previous Treatment: Cases where biliary obstruction has been technically successfully relieved through biliary drainage procedures with ERCP within 48 hours of hospitalization.
4. Consent: Written consent obtained from the patient or their legal representative for participation in this trial.
Circulatory insufficiency with catecholamines at ERCP time. ICU need. Hypothermia below 35 degrees Celsius. Recurrent cholangitis within 3 months. Biliary stricture >= Bismuth 2 or unclear biliary block. Post-surgery anatomical changes like biliary-jejunal anastomosis. Pancreatitis per International Pancreatic Society/American Pancreatic Association: Upper abdominal pain, serum amylase/lipase >3x ULN, acute pancreatitis imaging. Cholecystitis by TG18: A (Murphy's sign/right upper quadrant issues) + B (fever >37.1 degrees Celsius, CRP >3.0 mg/dL, WBC >10,000 uL) + C (acute cholecystitis imaging). Hepatic abscess. Other infections. Pre-registration continuous antibiotics. Pre-registration ERCP complications (perforation, pancreatitis, bleeding, cholecystitis, sedation-related issues). Immunosuppression: A (>10 mg prednisolone), B (HIV), C (neutrophils <=1500 uL), D (recent hematopoietic stem cell transplantation). Pregnancy. Other exclusions by physician.
210
1st name | Sakue |
Middle name | |
Last name | Masuda |
Shonan Kamakura General Hospital
Gastroenterology medicine center
247-8533
Okamoto 1370-1, Kamakura, Kanagawa
0467-46-1717
sakue.masuda@tokushukai.jp
1st name | Sakue |
Middle name | |
Last name | Masuda |
Shonan Kamakura General Hospital
Gastroenterology medicine center
247-8533
Okamoto 1370-1, Kamakura, Kanagawa
0467-46-1717
sakue.masuda@tokushukai.jp
Shonan Kamakura General Hospital
Shonan Kamakura General Hospital
Self funding
The Tokushukai Group Ethics Committee
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
03-3263-4801
homepage@tokushukai.jp
NO
2024 | Year | 04 | Month | 09 | Day |
Unpublished
Preinitiation
2024 | Year | 03 | Month | 07 | Day |
2024 | Year | 04 | Month | 15 | Day |
2027 | Year | 03 | Month | 31 | Day |
2024 | Year | 04 | Month | 05 | Day |
2024 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061735
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