Effect of 3D Typing on Surgical Treatment of Hepatolithiasis

Not Applicable

• Conditions: Hepatolithiasis; Surgery
• Interventions: Procedure: routine typing; Procedure: 3D typing

• 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

Arm && Interventions

Group	Intervention	Description
routine typing	routine typing	typing the patient with routine typing system and give treatment according preestablished algorism in our center.
3D typing	3D typing	typing the patient with 3D typing system and give treatment according preestablished algorism in our center.

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