NIPH Clinical Trials Search

Study of Temporary Biliary Stenting to Prevent Cholangitis After Endoscopic Treatment of Common Bile Duct Stones

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Common bile duct stones without acute cholangitis undergoing complete stone removal by ERCP
Date of first enrollment	13/05/2026
Target sample size	186
Countries of recruitment
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome	Incidence of post-ERCP cholangitis within 1-7 days after ERCP based on modified TG18 criteria
Secondary Outcome	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 Length of hospital stay after ERCP Incidence of ERCP related adverse events Revisit or readmission rate within 30 days after ERCP

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	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.
Exclude criteria	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