Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma

NCT05907772 | Completed

• 1 other identifier: CT2023-ZJU-OBS1
• Study Type: observational
• Target: 522
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center study in China to investigate the role of PIVKA-II in HCC recipient selection and prognostic stratification by analyzing the data of 522 recipients with HCC registered in the China Liver Transplant Registry.

Conditions

Cancer of Liver

Outcome Measures

Primary Outcomes (1)

• Overall survival

  the overall survival of liver transplant recipient with HCC

  January 2015 to December 2020

Study Arms (2)

Recipients with preoperative PIVKA-II≤240mAU/mL

Other: No intervention

Recipients with preoperative PIVKA-II>240mAU/mL

Other: No intervention

Interventions

No intervention OTHER

No intervention

Recipients with preoperative PIVKA-II>240mAU/mL; Recipients with preoperative PIVKA-II≤240mAU/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 522 HCC patients underwent liver transplant with pre-operative PIVKA-II records were studied.

You may qualify if:

• The HCC patients received LT with pre-operative PIVKA-II records performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.

You may not qualify if:

• (1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Wang K, Dong L, Lu Q, Yang Z, Fan X, Gao F, Ge W, Wang Z, Zhou Z, Lu D, Wei X, Wei Q, Zhuang L, Qin L, Ye Q, Yang J, Dong J, Zheng S, Xu X. Incorporation of protein induced by vitamin K absence or antagonist-II into transplant criteria expands beneficiaries of liver transplantation for hepatocellular carcinoma: a multicenter retrospective cohort study in China. Int J Surg. 2023 Dec 1;109(12):4135-4144. doi: 10.1097/JS9.0000000000000729.

  PMID: 37988413 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: August 27, 2022
• Primary Completion: October 25, 2022
• Study Completion: November 10, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)