Hepatectomy for Early-stage HCC Patients With CSPH

May 30, 2022 updated by: Tongji Hospital

Clinically Significant Portal Hypertension (CSPH) on Early-stage HCC Following Hepatectomy: What's the Impact?

Clinically significant portal hypertension (CSPH) can affect the surgical prognosis of early-stage (BCLC stage A) HCC. An additional stage, such as the BCLC stage A-B, can be considered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

311 HCC patients treated from December 2009 to January 2017.

Description

Inclusion Criteria:

HCC was diagnosed by two experienced pathologists in Child-Pugh grade A/B negative resection margin Initial diagnosis of HCC in the patients

Exclusion Criteria:

Distant transfer Not HCC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-CSPH
BCLC stage A patients who underwent hepatectomy in the group without clinically significant portal hypertension (Non-CSPH)
Procedure: hepatectomy
Liver resection
CSPH
BCLC stage A patients who underwent hepatectomy in the group with clinically significant portal hypertension (CSPH)
Procedure: hepatectomy
Liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 2009--2025
Patient survival time after surgery
2009--2025
recurrence
Time Frame: 2009--2025
Patient recurrence time after surgery
2009--2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXPJJH11800001-2018306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HCC

Clinical Trials on hepatectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe