Effect of 3D Typing on Surgical Treatment of Hepatolithiasis

Not Applicable

• Conditions: Hepatolithiasis; Surgery

• Registration Number: NCT03098251
• Lead Sponsor: Southwest Hospital, China

Brief Summary

According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis.

Detailed Description

According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis. In this cohort study, two group will be enrolled to compare the outcomes.

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Status Verified: 2017-04
• Study Start: 2017-04-11
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Aged from 18 to 65 years old
• Without gender restriction
• With a favorable liver function of Child-Pugh A to B
• No contraindications to surgery and anesthesia
• Diagnosed with Hepatolithiasis and Signed informed consent.

Exclusion Criteria

• Diffused type of Hepatolithiasis
• Impairment in liver function
• Severe disorders in vital organ
• Accompanied with tumors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
residual ratio of biliary stone	3 months	residual ratio of biliary stone diagnosed within 3 months

Secondary Outcome Measures

Name	Time	Method
residual lesions	6 months	residual lesions diagnosed within 6 months
postoperative complications	6 months	postoperative complications diagnosed within 6 months
Health economics index	3 months	Health economics index within 3 months
mortality	3 months	mortality occured within 3 months

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China