Hepatocellular CarcinomaNCT04076631
Surgical Stages of Liver Cirrhosis In Patients With Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Chen Xiaoping at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zhiyong Huang, +86 27 83665392, zyhuang126@126.com
About this study
Official title: A Prospective, Multicenter Clinical Study On Surgical Stages of Liver Cirrhosis In Patients With HBV-Related Hepatocellular Carcinoma
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).
Read the detailed description
HCC is the fifth most common malignancy in the world and ranks the third leading cause of tumor-related mortality. In China, more than 80% of HCC patients are accompanied by liver cirrhosis. Varied degrees of cirrhosis not only play an important role in selecting appropriate operative interventions for HCC patients, but are closely associated with tumor recurrence and long-term survival as well. Therefore, evaluating cirrhotic severity is essential for individualizing surgical modalities and predicting outcomes for patients with HCC. In recent years, investigators' group has proposed to stage the severity of liver cirrhosis through intraoperative liver morphological changes and preoperative cirrhotic severity scoring (TJ-CSS) model. Although the morphological classification of liver cirrhosis is of guiding significance for surgeons to determine the extent of hepatectomy, this method has some defects, such as subjectivity, lack of specific quantitative indicators and so on. Based on this, investigators propose to evaluate the severity of liver cirrhosis by measuring liver stiffness directly by Shaw hardmeter. Therefore, this prospective, multicenter clinical study intends to modify and perfect the preoperative cirrhotic severity scoring (TJ-CSS) and direct measurement of liver stiffness (DMS) grade established in the early period, so as to build a set of clinical standards for surgical liver cirrhosis classification, which can be used to guide the surgical treatment of HCC.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular Carcinoma | Patients with hepatocellular carcinoma undergo open hepatectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 10 days prior to hepatectomy
Liver stiffness measurement
Liver stiffness will be measured by LX-C Shaw hardmeter.
Measured: during operation
Pathological stage of liver cirrhosis
Liver cirrhosis will be sub-staged according to Laennec staging system
Measured: 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)
PHLF was diagnosed by the "50-50 criteria" characterized by the combination of a prothrombin time index of <50% and serum total bilirubin level of >50 mmol/L on postoperative day 5
Measured: postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Aug 2019
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaoping, Tongji Hospital
- Investigators
- Xiaoping Chen, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076631
- Sponsor's protocol ID
- CXPJJH11900009
- Status last verified
- Oct 2020
- First submitted
- 13 Aug 2019
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38617471
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study On Surgical Stages of Liver Cirrhosis In Patients With HBV-Related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04076631
- Acronym / sponsor ID
- CXPJJH11900009
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chen XiaopingUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
HCC is the fifth most common malignancy in the world and ranks the third leading cause of tumor-related mortality. In China, more than 80% of HCC patients are accompanied by liver cirrhosis. Varied degrees of cirrhosis not only play an important role in selecting appropriate operative interventions for HCC patients, but are closely associated with tumor recurrence and long-term survival as well. Therefore, evaluating cirrhotic severity is essential for individualizing surgical modalities and predicting outcomes for patients with HCC. In recent years, investigators' group has proposed to stage the severity of liver cirrhosis through intraoperative liver morphological changes and preoperative cirrhotic severity scoring (TJ-CSS) model. Although the morphological classification of liver cirrhosis is of guiding significance for surgeons to determine the extent of hepatectomy, this method has some defects, such as subjectivity, lack of specific quantitative indicators and so on. Based on this, investigators propose to evaluate the severity of liver cirrhosis by measuring liver stiffness directly by Shaw hardmeter. Therefore, this prospective, multicenter clinical study intends to modify and perfect the preoperative cirrhotic severity scoring (TJ-CSS) and direct measurement of liver stiffness (DMS) grade established in the early period, so as to build a set of clinical standards for surgical liver cirrhosis classification, which can be used to guide the surgical treatment of HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular Carcinoma | – | –Patients with hepatocellular carcinoma undergo open hepatectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative assessment of cirrhotic severity by cirrhotic severity scoring (TJ-CSS)
Time frame: within 10 days prior to hepatectomy
The calculation of TJ-CSS will be based on four clinical parameters (esophageal varices severity, portal vein diameter, spleen thickness and platelet account).
Liver stiffness measurement
Time frame: during operation
Liver stiffness will be measured by LX-C Shaw hardmeter.
Pathological stage of liver cirrhosis
Time frame: Within 30 days after surgery
Liver cirrhosis will be sub-staged according to Laennec staging system
1 secondary outcome
The effect of cirrhotic severity and extent of hepatectomy on the incidence of post-hepatectomy liver failure (PHLF)
Time frame: postoperative day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Derived from this study: PubMed 38617471Liang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoping Chen principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Chen Xiaoping at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong Huang (+86 27 83665392, zyhuang126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative assessment of cirrhotic severity by cirrhotic severity scoring (TJ-CSS) (time frame: within 10 days prior to hepatectomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04076631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.