Rapid Assessment of Donor Liver Quality | NCT03647059

Studies
Rapid Assessment of Donor Liver Quality

NCT03647059

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Aug 27, 2018Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Transplant; Failure, Liver

Interventions

LSCM examination

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2018Estimated

Primary Completion Date

Aug 15, 2020Estimated

Completion Date

Aug 15, 2022Estimated

First Submitted Date

Aug 9, 2018

First Submission Date that Met QC Criteria

Aug 22, 2018

First Posted Date

Aug 27, 2018Actual

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

Aug 22, 2018

Last Update Posted Date

Aug 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Zhong, Director of hepatobiliary surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Aims：

Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system
Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.)
Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results.
LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation.
LSCM grades the quality of donor liver and compares the long-term prognosis

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LSCM examination			Diagnostic Test: LSCM examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LSCM examination	Diagnostic Test	Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein	LSCM examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LSCM examination results	LSCM examination is focus on the detections of the hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on).	1 day

Secondary Outcomes

Measure	Description	Time Frame
HE section staining pathological examination	All of donor livers must be detected by HE section staining pathological examination and it is mainly focused on the detection of hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on).	1 week

Other Outcomes

Measure	Description	Time Frame
Clinical examinations	Mainly focus on the examinations such as ALT、AST、LDH and so on.	1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All donor livers to be used for liver transplantations

Exclusion Criteria:

Exclusion of multiple organ transplantation
Exclusion of detached transplantation and partial liver transplantation, etc.
Removal of blood type incompatible patients for transplantation
Exclusion of poor donor liver quality due to surgical technique (such as hepatic artery embolization) , portal vein thrombosis, etc.)
Any form of substance abuse, mental illness or any disease that the investigator believes may interfere with the patient's understanding of the research requirements.
Can not complete routine research follow-up, and other circumstances that the investigator believes are not suitable for the experiment.

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

All donor livers to be used for liver transplantations. Before transplant, the donor liver will be stored in the cold-UW solution in ice water. We just cut a piece of liver simple in the any place of donor liver, usually, we always cut a piece of liver simple from the edge of the donor liver.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhong Lin, Doctor	Contact	13917603139		fox2189@163.com

Overall Officials

Name	Affiliation	Role
Zhong Lin, doctor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine		Shanghai	Shanghai Municipality	200080	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

positive IPD is available to other researchers

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided