Dysplastic Nodule of LiverNCT02793791
Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients
A study testing minimally invasive ablation therapies in people with Dysplastic Nodule of Liver and Chronic Hepatitis B, run by Shandong Cancer Hospital and Institute.
Trial summary
The aim of this study is to determine that for hepatic dysplastic nodules in patients with chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive ablation therapy can reduce the incidence of hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dysplastic Nodule of Liver, Chronic Hepatitis B
- What is being tested?
- minimally invasive ablation therapies
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic HBV
- Diagnosis of hepatic dysplastic nodule(s) be confirmed by biopsy.
Who cannot join
- concurrent HCV infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prophylactic Minimally-invasive Local Ablation Therapies for the Hepatic Dysplastic Nodules in Patients With Positive Hepatitis B Surface Antigen (HBsAg).
The aim of this study is to determine that for hepatic dysplastic nodules in patients with chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive ablation therapy can reduce the incidence of hepatocellular carcinoma.
Read the detailed description
Hepatic dysplastic nodules (DNs) include high grade dysplastic nodules (HGDNs) and low grade dysplastic nodule (LGDNs), their incidences are high in patients with liver cirrhosis. Once diagnosed, all latest versions of the major guidelines recommend enhanced follow-up, and no treatment would be provided until the diagnosis of hepatocellular carcinoma (HCC) is established during the follow-up.
While on the other hand, mounting evidence shows that DNs have relatively high transition rate to progress to HCC. In 154 patients with chronic hepatitis and cirrhosis, Kobayashi et al. reported the annual transition rate of 20% for patients with HGDN and 10% for patients with LGDN. The 5-year cumulative transition rate from HGDN and LGDN was 80.8% and 30.2%, respectively. Even regenerative nodules (RNs) without dysplasia evolved into HCC in 12.4%.More recently, Sato et al. studied 68 large regenerative nodules (LRNs) and 20 DNs from 1,500 consecutive nodular lesions; the 50-month transition rate was 13.6% in LRNs and 40% in DNs. Earlier studies support these findings.
Adenomatous polyps are accepted precursors to colorectal cancer (CRC) and removed to prevent cancer. Compared to the above transition rates, A recent cohort study estimated that the average annual transition rate from advanced adenoma to CRC in men was 3.1%,so the 5-year-transition rate was around 15%. Since the transition rate of hepatic DNs is much higher than the colorectal adenomatous polyps, is "enhanced follow-up" really the best choice of the treatment?
So in this proposed clinical trial, we hypothesize that for hepatic DNs discovered in patients with chronic hepatitis B, early minimally-invasive ablation treatment will decrease the incidence of HCC.
Recruited patients will be divided in to two groups randomly, in the "Observation group", patients will be followed-up and receive no therapy; while in the "Ablation group", the DNs will be ablated by minimally-invasive ablation therapies, including RFA, PEI, MWA, etc. All patients will be followed-up according to the AASLD guideline. Then the incidence of HCC of the two arms will be compared.
- Conditions
- Dysplastic Nodule of Liver, Chronic Hepatitis B
- Being tested
- minimally invasive ablation therapies
- Keywords
- high grade dysplastic nodule (HGDN), low grade dysplastic nodule (LGDN)
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive ablation therapiesProcedure or surgery
Including RFA (radiofrequency ablation);MWA (microwave ablation); PEI (percutaneous ethanol injection),etc.
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Not described Receives: Procedure: minimally invasive ablation therapies |
| Observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatocellular carcinoma during the follow-up
The diagnosis of hepatocellular carcinoma during the follow-up will follow the AASLD practice guideline for the management of hepatocellular carcinoma (2010)
Measured: Up to 70 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dysplastic Nodule of LiverStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei ZHAO, Shandong Cancer Hospital and Institute
- Investigators
- Lei Zhao, MD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793791
- Sponsor's protocol ID
- SDCHI-HDN
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
PubMed 21374666European Association for Study of Liver; European Organisation for Research and Treatment of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. Eur J Cancer. 2012 Mar;48(5):599-641. doi: 10.1016/j.ejca.2011.12.021. No abstract available.
PubMed 22424278Kobayashi M, Ikeda K, Hosaka T, Sezaki H, Someya T, Akuta N, Suzuki F, Suzuki Y, Saitoh S, Arase Y, Kumada H. Dysplastic nodules frequently develop into hepatocellular carcinoma in patients with chronic viral hepatitis and cirrhosis. Cancer. 2006 Feb 1;106(3):636-47. doi: 10.1002/cncr.21607.
PubMed 16369988Sato T, Kondo F, Ebara M, Sugiura N, Okabe S, Sunaga M, Yoshikawa M, Suzuki E, Ogasawara S, Shinozaki Y, Ooka Y, Chiba T, Kanai F, Kishimoto T, Nakatani Y, Fukusato T, Yokosuka O. Natural history of large regenerative nodules and dysplastic nodules in liver cirrhosis: 28-year follow-up study. Hepatol Int. 2015 Apr;9(2):330-6. doi: 10.1007/s12072-015-9620-6. Epub 2015 Mar 3.
PubMed 25788204Brenner H, Altenhofen L, Stock C, Hoffmeister M. Natural history of colorectal adenomas: birth cohort analysis among 3.6 million participants of screening colonoscopy. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1043-51. doi: 10.1158/1055-9965.EPI-13-0162. Epub 2013 Apr 30.
PubMed 23632815
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Minimally-invasive Local Ablation Therapies for the Hepatic Dysplastic Nodules in Patients With Positive Hepatitis B Surface Antigen (HBsAg).
- ClinicalTrials.gov ID
- NCT02793791
- Acronym / sponsor ID
- SDCHI-HDN
- Conditions
- Dysplastic Nodule of Liver, Chronic Hepatitis B
- Keywords
- high grade dysplastic nodule (HGDN), low grade dysplastic nodule (LGDN)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Jun 2016 (estimated)
- 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 aim of this study is to determine that for hepatic dysplastic nodules in patients with chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive ablation therapy can reduce the incidence of hepatocellular carcinoma.
Detailed description
Hepatic dysplastic nodules (DNs) include high grade dysplastic nodules (HGDNs) and low grade dysplastic nodule (LGDNs), their incidences are high in patients with liver cirrhosis. Once diagnosed, all latest versions of the major guidelines recommend enhanced follow-up, and no treatment would be provided until the diagnosis of hepatocellular carcinoma (HCC) is established during the follow-up.
While on the other hand, mounting evidence shows that DNs have relatively high transition rate to progress to HCC. In 154 patients with chronic hepatitis and cirrhosis, Kobayashi et al. reported the annual transition rate of 20% for patients with HGDN and 10% for patients with LGDN. The 5-year cumulative transition rate from HGDN and LGDN was 80.8% and 30.2%, respectively. Even regenerative nodules (RNs) without dysplasia evolved into HCC in 12.4%.More recently, Sato et al. studied 68 large regenerative nodules (LRNs) and 20 DNs from 1,500 consecutive nodular lesions; the 50-month transition rate was 13.6% in LRNs and 40% in DNs. Earlier studies support these findings.
Adenomatous polyps are accepted precursors to colorectal cancer (CRC) and removed to prevent cancer. Compared to the above transition rates, A recent cohort study estimated that the average annual transition rate from advanced adenoma to CRC in men was 3.1%,so the 5-year-transition rate was around 15%. Since the transition rate of hepatic DNs is much higher than the colorectal adenomatous polyps, is "enhanced follow-up" really the best choice of the treatment?
So in this proposed clinical trial, we hypothesize that for hepatic DNs discovered in patients with chronic hepatitis B, early minimally-invasive ablation treatment will decrease the incidence of HCC.
Recruited patients will be divided in to two groups randomly, in the "Observation group", patients will be followed-up and receive no therapy; while in the "Ablation group", the DNs will be ablated by minimally-invasive ablation therapies, including RFA, PEI, MWA, etc. All patients will be followed-up according to the AASLD guideline. Then the incidence of HCC of the two arms will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Procedure: minimally invasive ablation therapies |
| Observation | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic HBV
- Diagnosis of hepatic dysplastic nodule(s) be confirmed by biopsy.
Key exclusion criteria (1 listed)
- concurrent HCV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive ablation therapiesIncluding RFA (radiofrequency ablation);MWA (microwave ablation); PEI (percutaneous ethanol injection),etc. | Procedure or surgery | Ablation |
Primary outcome
Incidence of hepatocellular carcinoma during the follow-up
Time frame: Up to 70 months
The diagnosis of hepatocellular carcinoma during the follow-up will follow the AASLD practice guideline for the management of hepatocellular carcinoma (2010)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Background: PubMed 21374666Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
- Background: PubMed 22424278European Association for Study of Liver; European Organisation for Research and Treatment of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. Eur J Cancer. 2012 Mar;48(5):599-641. doi: 10.1016/j.ejca.2011.12.021. No abstract available.
- Background: PubMed 16369988Kobayashi M, Ikeda K, Hosaka T, Sezaki H, Someya T, Akuta N, Suzuki F, Suzuki Y, Saitoh S, Arase Y, Kumada H. Dysplastic nodules frequently develop into hepatocellular carcinoma in patients with chronic viral hepatitis and cirrhosis. Cancer. 2006 Feb 1;106(3):636-47. doi: 10.1002/cncr.21607.
- Background: PubMed 25788204Sato T, Kondo F, Ebara M, Sugiura N, Okabe S, Sunaga M, Yoshikawa M, Suzuki E, Ogasawara S, Shinozaki Y, Ooka Y, Chiba T, Kanai F, Kishimoto T, Nakatani Y, Fukusato T, Yokosuka O. Natural history of large regenerative nodules and dysplastic nodules in liver cirrhosis: 28-year follow-up study. Hepatol Int. 2015 Apr;9(2):330-6. doi: 10.1007/s12072-015-9620-6. Epub 2015 Mar 3.
- Background: PubMed 23632815Brenner H, Altenhofen L, Stock C, Hoffmeister M. Natural history of colorectal adenomas: birth cohort analysis among 3.6 million participants of screening colonoscopy. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1043-51. doi: 10.1158/1055-9965.EPI-13-0162. Epub 2013 Apr 30.
- Individual participant dataSharing planned: Undecided
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.
Lei Zhao, MD principal investigator
Shandong Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive ablation therapies in people with Dysplastic Nodule of Liver and Chronic Hepatitis B, run by Shandong Cancer Hospital and Institute.
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 2 inclusion and 1 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 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Lei Zhao, MD (+8653167626368, drzhaolei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hepatocellular carcinoma during the follow-up (time frame: Up to 70 months). 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 NCT02793791, which also lists 5 linked publications.
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 8 Jun 2016.