Effect of 3D Typing on Surgical Treatment of Hepatolithiasis

NCT ID: NCT03098251

Last Updated: 2017-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Hepatolithiasis Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3D typing

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

Group Type EXPERIMENTAL

3D typing

Intervention Type PROCEDURE

typing the patient with 3D typing system and give specific treatment

routine typing

typing the patient with routine typing system and give treatment according preestablished algorism in our center.

Group Type ACTIVE_COMPARATOR

routine typing

Intervention Type PROCEDURE

typing the patient with routine typing system and give specific treatment

Interventions

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3D typing

typing the patient with 3D typing system and give specific treatment

Intervention Type PROCEDURE

routine typing

typing the patient with routine typing system and give specific treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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feng xiaobin

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaobin Feng, MD

Role: CONTACT

+86-2368765297

Facility Contacts

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xiaobin Feng, MD

Role: primary

Other Identifiers

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SWHB017

Identifier Type: -

Identifier Source: org_study_id

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