Clinical trial · Observational
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
NCT04076631CI-TRIAL-00047616unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Hepatocellular Carcinoma
- description
- Patients with hepatocellular carcinoma undergo open hepatectomy.
Primary outcomes (3)
- measure
- Preoperative assessment of cirrhotic severity by cirrhotic severity scoring (TJ-CSS)
- timeFrame
- within 10 days prior to hepatectomy
- description
- The calculation of TJ-CSS will be based on four clinical parameters (esophageal varices severity, portal vein diameter, spleen thickness and platelet account).
- measure
- Liver stiffness measurement
- timeFrame
- during operation
- description
- Liver stiffness will be measured by LX-C Shaw hardmeter.
- measure
- Pathological stage of liver cirrhosis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, 18 to 75 years of age, inclusive. 2. Patients who are clinically diagnosed as hepatocellular carcinoma and confirmed by postoperative pathology. 3. 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. 4. Patients who undergo open surgery. 5. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery. 6. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with tumors that oppress the main portal vein or main portal vein thrombus. 2. Patients that are accompanied with cavernous degeneration of portal vein. 3. Patients with hypersplenism caused by diseases of the blood system. 4. Patients suffer from serious acute and chronic diseases. 5. Patients with severe infectious diseases. 6. Patients with HIV-infectious or other AIDS-related disease. 7. Patients are drug abusers or have any psychological or mental conditions that potentially lead to poor study compliance. 8. Patients have any condition that in the judgement of the investigators would make the subject inappropriate for entry into this study.
References
Publications (1)
- DERIVEDLiang 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 38617471