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Management of difficult common bile duct stones using peroral cholangioscopy based on ALARA concept: a multi-center, prospective non-randomized concurrent controlled trial

Management of difficult common bile duct stones using peroral cholangioscopy based on ALARA concept: a multi-center, prospective non-randomized concurrent controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083860
Enrollment
Unknown
Registered
2024-05-06
Start date
2024-05-06
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

difficult common bile duct stones

Interventions

test group (POC group):Use of POC in the management
control group (cERCP group):conventional ERCP management

Sponsors

People's Hospital of Leshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: ?patients over 18 years of age;? patients with a diagnosis of difficult CBD stones established by at least one imaging study including computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound (EUS), which revealed at least one of the following items: the maximal diameter of a single stone over 1.5cm, the total number of stones exceeded 5, concomitant left or right hepatic duct stones, concomitant cystic duct stones, stricture of the common bile duct distal to the stone;?patients able to offer written informed consent.

Exclusion criteria

Exclusion criteria: ?patients with severe concomitant diseases such as heart, hepatic, renal, pulmonary insufficiency or malignancy; ?patients with a history of Billroth II or Roux-en-Y anastomosis; ? the diameter of CBD distal to stones not exceeding 4mm; ?pregnancy or lactation;?coagulopathy;? hypersensitive to any medication or instrument relevant to the trial.

Design outcomes

Primary

MeasureTime frame
one-session stone clearance ;radiation exposure time;dosage area product;

Secondary

MeasureTime frame
procedure-related cost;cost-effectiveness ratio;length of hospital stay;stone occurrence rate at 6-month follow-up;

Countries

China

Contacts

Public ContactYu Tang

People's Hospital of Leshan

tangyuchinatown@163.com+86 833 211 9337

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026