Hepatectomy for Early-stage HCC Patients With CSPH

• Sponsor: Tongji Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05402644
• Collaborator: (none)
• Enrollment: 320
• Actual Duration (Months): 145

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HCC; Portal Hypertension	Procedure: hepatectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 320 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Clinically Significant Portal Hypertension (CSPH) on Early-stage HCC Following Hepatectomy: What's the Impact?
• Actual Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. death [2009--2025]

   Patient survival time after surgery

2. recurrence [2009--2025]

   Patient recurrence time after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tongji Hospital
• ClinicalTrials.gov Identifier: NCT05402644
• Other Study ID Numbers: CXPJJH11800001-2018306
• First Posted: Jun 2, 2022
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension, Portal; Hypertension

Study Results

No Results Posted as of Jun 2, 2022