臨床研究等提出・公開システム

Short-Term Prophylactic Biliary Stenting After Complete Common Bile Duct Stone Removal for Prevention of Post-ERCP Cholangitis: A Multicenter Randomized Controlled Trial (Short-Term Prophylactic Biliary Stenting After Complete Common Bile Duct Stone Removal for Prevention of Post-ERCP Cholangitis: A Multicenter Randomized Controlled Trial (STEP-ERCP))

Study of Temporary Biliary Stenting to Prevent Cholangitis After Endoscopic Treatment of Common Bile Duct Stones (Study of Temporary Biliary Stenting to Prevent Cholangitis After Endoscopic Treatment of Common Bile Duct Stones (STEP-ERCP))

Hasegawa Sho

Yokohama City University

3-9, Fukuura, kanazawa-ku, Yokohama, Kanagawa

t166064d@yokohama-cu.ac.jp

Hasegawa Sho

Yokohama City University

3-9, Fukuura, kanazawa-ku, Yokohama, Kanagawa

+81-45-787-2640

t166064d@yokohama-cu.ac.jp

Pending

May. 13, 2026

Interventional

randomized controlled trial

open(masking not used)

placebo control

parallel assignment

treatment purpose

Patients aged 20 years or older at registration.
Patients diagnosed with common bile duct stones by imaging studies and scheduled to undergo ERCP.
Patients who do not meet the suspected or definite diagnosis of acute cholangitis based on Tokyo Guidelines 2018 immediately before ERCP.
Patients whose hepatobiliary enzymes are within three times the upper limit of normal at each institution.
Patients with body temperature less than 38.0 degrees C, white blood cell count 4000 to 10000/uL, and CRP less than 1.0 mg/dL immediately before ERCP.
Patients who have provided written informed consent after receiving sufficient explanation of the study.

Patients diagnosed with suspected or definite acute cholangitis based on Tokyo Guidelines 2018 at the time of ERCP or within 2 weeks before ERCP
Patients in whom standard ERCP is difficult or non-standard, including malignant biliary stricture, ampullary tumor, or surgically altered anatomy other than Billroth I reconstruction
Patients with serious safety concerns, such as biliary perforation, severe infection, or markedly poor general condition
Patients with severe cardiopulmonary disease or renal failure who cannot tolerate endoscopic treatment under general anesthesia or sedation
Patients judged by the investigator or sub-investigator to be inappropriate for study participation for medical reasons

Both

Common bile duct stones without acute cholangitis undergoing complete stone removal by ERCP

Patients who undergo complete common bile duct stone removal by ERCP will be randomly assigned to either prophylactic biliary stenting or no stenting.
In the intervention group, a spontaneously dislodging plastic biliary stent (BIT stent) will be placed immediately after ERCP for temporary biliary drainage.
In the control group, no biliary stent will be placed after ERCP, and patients will receive standard post-ERCP management.

Common bile duct stones, Choledocholithiasis, ERCP, Cholangitis, Biliary stent

Biliary stent, BIT stent, ERCP, Prophylactic biliary drainage, Spontaneously dislodging stent

Choledocholithiasis

Stents, Endoscopic Retrograde Cholangiopancreatography

Incidence of post-ERCP cholangitis within 1-7 days after ERCP based on modified TG18 criteria

Severity of post ERCP cholangitis
Time to onset of post ERCP cholangitis
Proportion of patients requiring therapeutic antibiotic treatment after ERCP
Proportion of patients requiring repeat ERCP or biliary drainage after ERCP
Incidence of ERCP related adverse events
Revisit or readmission rate within 30 days after ERCP

+81-45-370-7627

May. 11, 2026

No

none