Hepatocellular CarcinomaNCT06005883
Surgical Outcome of HCC With Portal Vein Tumor Thrombosis on the Basis of Risk Scoring
An observational study of Hepatocellular Carcinoma and Portal Vein Thrombosis, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
The goal of this multicenter retrospective cohort study is to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma, Portal Vein Thrombosis, Prognosis
- How many people
- 332 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2021to 10 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective multicenter study enrolled patients who underwent surgical resection of HCC with PVTT at 10 university-affiliated hospitals in Korea between January 2005 and December 2019. The institutional review board of each study center approved the study protocol (IRB No.:2022-03-065-003). The inclusion criteria were as follows: a) HCC with PVTT found on preoperative imaging and proven by postoperative histology whether it is viable; b) Child-Pugh class A liver function; c) no extrahepatic metastasis and concomitant malignant tumors other than HCC; d) no previous hepatic resection for HCC; and e) available medical records and/or imaging studies.
Who may be able to join
- The patients underwent liver resection for HCC with portal vein tumor thrombosis between Jan 2005 and Dec 2019 at 10 university-affiliated hospitals in South Korea.
Who cannot join
- Metastatic cancer \& extrahepatic metastasis
- Intrahepatic cholangiocarcinoma
- Mixed type hepatocellular-cholangiocarcinoma
- Recurred hepatocellular carcinoma
- not available medical records.
- Child-Pugh classification B or C
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung university Dongsan Medical Center
Daegu, DalSeo-gu, 42601
About this study
Official title: The Prognosis After Surgical Resection in Patients With Hepatocellular Carcinoma Combined Portal Vein Tumor Thrombosis; Multicenter Retrospective Study
The goal of this multicenter retrospective cohort study is to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.
Read the detailed description
Hepatocellular carcinoma (HCC) frequently invades the surrounding liver vasculature, with portal vein tumor thrombosis (PVTT) being the most common form of macrovascular invasion. At the time of HCC diagnosis, PVTT is detected in approximately 10%-40% of patients and is associated with an extremely poor prognosis.
In most staging systems and guidelines, HCC with PVTT, regardless of the extent of the tumor, is classified as an advanced stage, and surgical resection is not recommended as the first-line treatment. Instead, consensus guidelines such as those from the American Association of Study of Liver Disease(AASLD), the Asian Pacific Association for the Study of Liver(APASL), and the European Association for the Study of Liver(EASL) recommend systemic and targeted therapy for these patients. Despite these recommendations, experienced liver centers in Asia have been attempting surgical resection for some patients with HCC exhibiting PVTT, and the outcomes are favorable in selected patients. However, most of the studies were conducted in only one center, had a small sample size, and obtained undesirable surgical treatment outcomes in most of the patients. Thus, surgical resection has not yet been widely accepted as an effective treatment for patients with HCC and PVTT. In addition, a prognostic index that can indicate which surgical resection is beneficial in comparison with nonsurgical treatment remains unestablished. A randomized controlled trial could be the best way to compare the outcomes of surgical resection and nonsurgical treatments, but it is difficult to conduct because of difficulties in ethical approval and allocation concealment. Therefore, adequate studies with large sample sizes are needed to clarify the benefits of surgical resection in patients with HCC and PVTT and the prognostic index, which can specify the criteria for surgical resection in these patients.
This study aimed to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.
- Conditions
- Hepatocellular Carcinoma, Portal Vein Thrombosis, Prognosis
- Keywords
- Hepatocellular carcinoma, portal vein tumor thrombosis, Prognosis, Hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Patient's death after surgical resection in HCC patients with portal vein tumor thrombosis
Measured: From the date of surgery until the date of patient's death from any cause, whichever came first, assessed up to November 2021.
Recurrence of tumor
HCC recurrence after surgical resection in HCC patients with portal vein tumor thrombosis
Measured: From the date of surgery until the date of HCC recurrence, whichever came first, assessed up to November 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start10 Apr 2021
- Primary completion10 Aug 2021
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005883
- Sponsor's protocol ID
- 2022-03-065-003
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognosis After Surgical Resection in Patients With Hepatocellular Carcinoma Combined Portal Vein Tumor Thrombosis; Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06005883
- Acronym / sponsor ID
- 2022-03-065-003
- Conditions
- Hepatocellular Carcinoma, Portal Vein Thrombosis, Prognosis
- Keywords
- Hepatocellular carcinoma, portal vein tumor thrombosis, Prognosis, Hepatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 23 Aug 2023 (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 goal of this multicenter retrospective cohort study is to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.
Detailed description
Hepatocellular carcinoma (HCC) frequently invades the surrounding liver vasculature, with portal vein tumor thrombosis (PVTT) being the most common form of macrovascular invasion. At the time of HCC diagnosis, PVTT is detected in approximately 10%-40% of patients and is associated with an extremely poor prognosis.
In most staging systems and guidelines, HCC with PVTT, regardless of the extent of the tumor, is classified as an advanced stage, and surgical resection is not recommended as the first-line treatment. Instead, consensus guidelines such as those from the American Association of Study of Liver Disease(AASLD), the Asian Pacific Association for the Study of Liver(APASL), and the European Association for the Study of Liver(EASL) recommend systemic and targeted therapy for these patients. Despite these recommendations, experienced liver centers in Asia have been attempting surgical resection for some patients with HCC exhibiting PVTT, and the outcomes are favorable in selected patients. However, most of the studies were conducted in only one center, had a small sample size, and obtained undesirable surgical treatment outcomes in most of the patients. Thus, surgical resection has not yet been widely accepted as an effective treatment for patients with HCC and PVTT. In addition, a prognostic index that can indicate which surgical resection is beneficial in comparison with nonsurgical treatment remains unestablished. A randomized controlled trial could be the best way to compare the outcomes of surgical resection and nonsurgical treatments, but it is difficult to conduct because of difficulties in ethical approval and allocation concealment. Therefore, adequate studies with large sample sizes are needed to clarify the benefits of surgical resection in patients with HCC and PVTT and the prognostic index, which can specify the criteria for surgical resection in these patients.
This study aimed to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective multicenter study enrolled patients who underwent surgical resection of HCC with PVTT at 10 university-affiliated hospitals in Korea between January 2005 and December 2019. The institutional review board of each study center approved the study protocol (IRB No.:2022-03-065-003). The inclusion criteria were as follows: a) HCC with PVTT found on preoperative imaging and proven by postoperative histology whether it is viable; b) Child-Pugh class A liver function; c) no extrahepatic metastasis and concomitant malignant tumors other than HCC; d) no previous hepatic resection for HCC; and e) available medical records and/or imaging studies.
Key inclusion criteria (1 listed)
- The patients underwent liver resection for HCC with portal vein tumor thrombosis between Jan 2005 and Dec 2019 at 10 university-affiliated hospitals in South Korea.
Key exclusion criteria (6 listed)
- Metastatic cancer \& extrahepatic metastasis
- Intrahepatic cholangiocarcinoma
- Mixed type hepatocellular-cholangiocarcinoma
- Recurred hepatocellular carcinoma
- not available medical records.
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
Death
Time frame: From the date of surgery until the date of patient's death from any cause, whichever came first, assessed up to November 2021.
Patient's death after surgical resection in HCC patients with portal vein tumor thrombosis
Recurrence of tumor
Time frame: From the date of surgery until the date of HCC recurrence, whichever came first, assessed up to November 2021.
HCC recurrence after surgical resection in HCC patients with portal vein tumor thrombosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Portal Vein Thrombosis, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 23 Aug 2023. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: From the date of surgery until the date of patient's death from any cause, whichever came first, assessed up to November 2021.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2023.