NCT03074708

Brief Summary

Background:The aim of the study is to value the application of three-dimensional visualization and three-dimensional printing in the hepatobiliary and pancreatic surgery.Method:From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

January 29, 2016

Last Update Submit

March 8, 2017

Conditions

Keywords

Three-Dimensional ImageThree Dimensional Printing

Outcome Measures

Primary Outcomes (1)

  • operative time

    operative time

    1 year

Secondary Outcomes (2)

  • intraoperative blood loss

    1 year

  • postoperative complications after surgery

    1 year

Study Arms (1)

3D visualization and 3D printing

OTHER

From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

Other: 3D visualization and 3D printing

Interventions

From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

3D visualization and 3D printing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • the hepatobiliary and pancreatic diseases

You may not qualify if:

  • none of the hepatobiliary and pancreatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of The Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Liver DiseasesPancreatic DiseasesBiliary Tract Diseases

Interventions

Printing, Three-Dimensional

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

TechnologyTechnology, Industry, and Agriculture

Study Officials

  • Chihua Fang, MD

    Zhujiang Hospital of The Southern Medical University

    STUDY CHAIR

Central Study Contacts

Chihua Fang, MD

CONTACT

Nan Xiang, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 29, 2016

First Posted

March 9, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations