Safety of high-level disinfection and sterilization for reprocessing the single-operator cholangioscopy in biliary tract disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250304001

Enrollment

Registered

2025-03-04

Start date

2025-03-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with biliary tract diseases who indicate to use cholangioscopy and accept to use reprocessing cholangioscopy biliary tract disease, reprocessing cholangioscopy, safety

Interventions

ATP level and culture of reprocessing single-operator cholangioscopy after high-level disinfection and sterilization, use of reprocessing single-operator cholangioscopy

Experimental Device

reprocessing single-operator cholangioscopy

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Participants with indications for single-operator cholangioscopy 2. Participants who consent to the use of reprocessing single-operator cholangioscopy

Exclusion criteria

Exclusion criteria: 1. Uncorrectable bleeding disorder or coagulopathy (platelets < 50,000 or INR > 1.5) 2. refuse the use of reprocessing single-operator cholangioscopy

Design outcomes

Primary

Measure	Time frame
pathogen detection rate from reprocessing single-operator cholangioscopy after high-level disinfection and sterilization at 1 week after culture percent	—

Secondary

Measure	Time frame
all bacteria detection rate from reprocessing single-operator cholangioscopy after high-level disinfection and sterilization at 1 week after culture percent,Level of Adenosine triphosphate that predicts the likelihood of pathogen detection from reprocessing single-operator cholangioscopy culture at the time after high-level disinfection or sterilization relative light unit (RLU),post-ERCP cholangitis within 30 days after procedure criteria from Tokyo guideline,reduction of carbon footprint from using reprocessing single-operator cholangioscopy Throughout the research period percent,comparison of overall and high-concerning pathogen contamination between HLD vs HLD/EtO for reprocessing cholangioscopy at 1 week after culture percent	—

Measure

Time frame

all bacteria detection rate from reprocessing single-operator cholangioscopy after high-level disinfection and sterilization at 1 week after culture percent,Level of Adenosine triphosphate that predicts the likelihood of pathogen detection from reprocessing single-operator cholangioscopy culture at the time after high-level disinfection or sterilization relative light unit (RLU),post-ERCP cholangitis within 30 days after procedure criteria from Tokyo guideline,reduction of carbon footprint from using reprocessing single-operator cholangioscopy Throughout the research period percent,comparison of overall and high-concerning pathogen contamination between HLD vs HLD/EtO for reprocessing cholangioscopy at 1 week after culture percent

—

Countries

Thailand

Contacts

Public ContactKanokwan Kidphoka

Phramongkutklao hospital

ploy.kid.002@gmail.com0836326699

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026