NCT05402644

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2021

Enrollment Period

7.1 years

First QC Date

May 26, 2022

Last Update Submit

May 30, 2022

Conditions

HCCPortal Hypertension

Outcome Measures

Primary Outcomes (2)

  • death

    Patient survival time after surgery

    2009--2025

  • recurrence

    Patient recurrence time after surgery

    2009--2025

Study Arms (2)

Non-CSPH

BCLC stage A patients who underwent hepatectomy in the group without clinically significant portal hypertension (Non-CSPH)

Procedure: hepatectomy

CSPH

BCLC stage A patients who underwent hepatectomy in the group with clinically significant portal hypertension (CSPH)

Procedure: hepatectomy

Interventions

hepatectomyPROCEDURE

Liver resection

CSPHNon-CSPH

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

311 HCC patients treated from December 2009 to January 2017.

You may qualify if:

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

You may not qualify if:

  • Distant transfer Not HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 2, 2022

Study Start

December 1, 2009

Primary Completion

January 1, 2017

Study Completion

January 1, 2022

Last Updated

June 2, 2022

Record last verified: 2021-05