Surgical Stages of Liver Cirrhosis In Patients With Hepatocellular Carcinoma
A Prospective, Multicenter Clinical Study On Surgical Stages of Liver Cirrhosis In Patients With HBV-Related Hepatocellular Carcinoma
1 other identifier
observational
1,000
1 country
1
Brief Summary
The investigators intend to perform a prospective, multicenter study to establish a set of clinical criteria for surgical stages of liver cirrhosis, which can be implemented to guide the surgical treatment of hepatocellular carcinoma (HCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 13, 2019
CompletedFirst Posted
Study publicly available on registry
September 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 12, 2020
October 1, 2020
1.3 years
August 13, 2019
October 9, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Preoperative assessment of cirrhotic severity by cirrhotic severity scoring (TJ-CSS)
The calculation of TJ-CSS will be based on four clinical parameters (esophageal varices severity, portal vein diameter, spleen thickness and platelet account).
within 10 days prior to hepatectomy
Liver stiffness measurement
Liver stiffness will be measured by LX-C Shaw hardmeter.
during operation
Pathological stage of liver cirrhosis
Liver cirrhosis will be sub-staged according to Laennec staging system
Within 30 days after surgery
Secondary Outcomes (1)
The effect of cirrhotic severity and extent of hepatectomy on the incidence of post-hepatectomy liver failure (PHLF)
postoperative day 5
Study Arms (1)
Hepatocellular Carcinoma
Patients with hepatocellular carcinoma undergo open hepatectomy.
Eligibility Criteria
Patients who undergo open liver resection with curative intent for HCC and meet the eligibility criteria from 6 hospitals in China (Wuhan Tongji Hospital, Wuhan Union Hospital, Wuhan Zhongnan hospital, Hubei Cancer Hospital, Shiyan Taihe Hospital, Xiangyang Central Hospital) will be selected.
You may qualify if:
- Male or female, 18 to 75 years of age, inclusive.
- Patients who are clinically diagnosed as hepatocellular carcinoma and confirmed by postoperative pathology.
- The liver function grade was Child-Pugh class A or class B, which can be restored to Child-Pugh class A within a short period of medical treatment.
- Patients who undergo open surgery.
- Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.
- Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- Patients with tumors that oppress the main portal vein or main portal vein thrombus.
- Patients that are accompanied with cavernous degeneration of portal vein.
- Patients with hypersplenism caused by diseases of the blood system.
- Patients suffer from serious acute and chronic diseases.
- Patients with severe infectious diseases.
- Patients with HIV-infectious or other AIDS-related disease.
- Patients are drug abusers or have any psychological or mental conditions that potentially lead to poor study compliance.
- Patients have any condition that in the judgement of the investigators would make the subject inappropriate for entry into this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chen Xiaopinglead
Study Sites (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Related Publications (1)
Liang BY, Zhang EL, Li J, Long X, Wang WQ, Zhang BX, Zhang ZW, Chen YF, Zhang WG, Mei B, Xiao ZY, Gu J, Zhang ZY, Xiang S, Dong HH, Zhang L, Zhu P, Cheng Q, Chen L, Zhang ZG, Zhang BH, Dong W, Liao XF, Yin T, Wu DD, Jiang B, Yuan YF, Zhang ZL, Chen YB, Li KY, Lau WY, Chen XP, Huang ZY. A combined pre- and intra-operative nomogram in evaluation of degrees of liver cirrhosis predicts post-hepatectomy liver failure: a multicenter prospective study. Hepatobiliary Surg Nutr. 2024 Apr 3;13(2):198-213. doi: 10.21037/hbsn-22-410. Epub 2023 Mar 15.
PMID: 38617471DERIVED
Biospecimen
Surgically resected non-tumor liver tissues will be retained
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoping Chen
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 13, 2019
First Posted
September 3, 2019
Study Start
August 1, 2019
Primary Completion
November 1, 2020
Study Completion
December 1, 2020
Last Updated
October 12, 2020
Record last verified: 2020-10