Effect of 3D Typing on Surgical Treatment of Hepatolithiasis

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03098251
• Other study ID #: SWHB017
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: April 11, 2017
• Start date: April 11, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2017
• Source: Southwest Hospital, China
• Contact: Xiaobin Feng, MD
• Phone: +86-2368765297
• Email: fengxiaobin200708[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatolithiasis
• Surgery

Intervention

Procedure:
• 3D typing
typing the patient with 3D typing system and give specific treatment
• routine typing
typing the patient with routine typing system and give specific treatment

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Hospital, China	Chinese PLA General Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	residual ratio of biliary stone	residual ratio of biliary stone diagnosed within 3 months	3 months
Secondary	postoperative complications	postoperative complications diagnosed within 6 months	6 months
Secondary	residual lesions	residual lesions diagnosed within 6 months	6 months
Secondary	Health economics index	Health economics index within 3 months	3 months
Secondary	mortality	mortality occured within 3 months	3 months