Effect of 3D Typing on Surgical Treatment of Hepatolithiasis

Efficacy of 3D Typing and Routine Typing on Surgical Treatment of Hepatolithiasis

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Hepatolithiasis
• Intervention / Treatment: Procedure: 3D typing; Procedure: routine typing

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D typing; typing the patient with 3D typing system and give treatment according preestablished algorism in our center.	Procedure: 3D typing; typing the patient with 3D typing system and give specific treatment
Active Comparator: routine typing; typing the patient with routine typing system and give treatment according preestablished algorism in our center.	Procedure: routine typing; typing the patient with routine typing system and give specific treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
residual ratio of biliary stone	residual ratio of biliary stone diagnosed within 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	postoperative complications diagnosed within 6 months	6 months
residual lesions	residual lesions diagnosed within 6 months	6 months
Health economics index	Health economics index within 3 months	3 months
mortality	mortality occured within 3 months	3 months

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Collaborators: Chinese PLA General Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SWHB017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No