Effect of 3D Typing on Surgical Treatment of Hepatolithiasis | NCT03098251

Studies
Effect of 3D Typing on Surgical Treatment of Hepatolithiasis

NCT03098251

Sponsor

Southwest Hospital, China

Status

Unknown status

Last Update Posted

Apr 12, 2017Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Hepatolithiasis
Surgery

Interventions

3D typing
routine typing

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2017Actual

Primary Completion Date

Dec 30, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Mar 27, 2017

First Posted Date

Mar 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2017

Last Update Posted Date

Apr 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

feng xiaobin, clinical professor, Southwest Hospital, ChinaPrincipal Investigator

Lead Sponsor

Southwest Hospital, ChinaOTHER

Collaborators

Name	Class
Second Affiliated Hospital, School of Medicine, Zhejiang University	OTHER
Chinese PLA General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3D typing	Experimental	typing the patient with 3D typing system and give treatment according preestablished algorism in our center.	Procedure: 3D typing
routine typing	Active Comparator	typing the patient with routine typing system and give treatment according preestablished algorism in our center.	Procedure: routine typing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D typing	Procedure	typing the patient with 3D typing system and give specific treatment	3D typing

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
postoperative complications	postoperative complications diagnosed within 6 months	6 months
residual lesions	residual lesions diagnosed within 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaobin Feng, MD	Contact	+86-2368765297		fengxiaobin200708@aliyun.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Hospital	Recruiting	Chongqing	Chongqing Municipality	400038	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided