Evaluation of the Efficacy of the Two-point Method in Percutaneous Transhepatic Choledoscopy and the Influence of the Long-term Recurrence of Hepatolithiasis

Not Applicable

Completed

• Conditions: Hepatolithiasis; Endoscopy, Digestive System

• Registration Number: NCT06839612
• Lead Sponsor: Shengjing Hospital

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。The main questions it aims to answer are:

① By comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the clinical effect of the two methods was judged.

② To analyze the probability of short-term complications of the two-point method during the operation and to judge its safety.

③ Patients were followed up after the two-point method to determine the recurrence rate of stones and the probability of long-term complications.

The researchers will compare the two-point method with conventional PTCS to evaluate its effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-20
• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• ≥18 years of age
• PTCS were only used for the treatment of hepatolithiasis
• patients receiving PTCS for the first time.

Exclusion Criteria

• PTCD failure and withdrawal from treatment due to patients' subjective wishes were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Technical success rate	up to 1 week
Clinical success rate	up to 1 week
Stone recurrence rate	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Bleeding	up to 2 weeks
Liver abscess	up to 2 weeks
Cholangitis	up to 2 weeks
Bile leakage	up to 2 weeks
Pancreatitis	up to 2 weeks
Thoracic complication	up to 2 weeks
Iatrogenic injury	up to 2 weeks