A Prospective Cohort Study on the Prediction of PHLF by Comparing the Prediction Model Based on VEGFA and PEDF With Indocyanine Green Clearance Test

Sponsor
Eastern Hepatobiliary Surgery Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05779098
Collaborator
(none)
500
24

Study Details

Study Description

Brief Summary

This study is a prospective cohort study. It is intended to develop a liver failure prediction model with high prediction efficiency by combining the content of VEGFA and PEDF in liver or serum with traditional pathophysiological indicators. Compare the prediction efficiency of the model with the previous liver failure prediction evaluation method, indocyanine green clearance test, to clarify its prediction ability and accurately predict postoperative liver failure.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Extensive hepatectomy

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Cohort Study on the Prediction of PHLF by Comparing the Prediction Model Based on VEGFA and PEDF With Indocyanine Green Clearance Test
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Extensive hepatectomy

Procedure: Extensive hepatectomy
Extensive hepatectomy

Outcome Measures

Primary Outcome Measures

  1. Postoperative liver failure [1-5 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Extensive hepatectomy in our hospital(≥ three Hepatic segment)

Exclusion Criteria:

Serious basic diseases Intolerable surgery Refuse to perform ICG test before operation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Eastern Hepatobiliary Surgery Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shen Feng, Dean of Clinical Research Institute of Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT05779098
Other Study ID Numbers:
  • 1312871874
First Posted:
Mar 22, 2023
Last Update Posted:
Mar 22, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2023