Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients

NCT ID: NCT02793791

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2022-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ablation

Group Type: EXPERIMENTAL

minimally invasive ablation therapies

Intervention Type: PROCEDURE

Including RFA (radiofrequency ablation);MWA (microwave ablation); PEI (percutaneous ethanol injection),etc.

Observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

minimally invasive ablation therapies

Including RFA (radiofrequency ablation);MWA (microwave ablation); PEI (percutaneous ethanol injection),etc.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with chronic HBV
• Diagnosis of hepatic dysplastic nodule(s) be confirmed by biopsy.

Exclusion Criteria

• concurrent HCV infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Lei ZHAO

Doctor; Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lei Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Central Contacts

Lei Zhao, MD

Role: CONTACT

drzhaolei@hotmail.com

+8653167626368

References

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.

Reference Type: BACKGROUND

PMID: 21374666 (View on PubMed)

European 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.

Reference Type: BACKGROUND

PMID: 22424278 (View on PubMed)

Kobayashi 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.

Reference Type: BACKGROUND

PMID: 16369988 (View on PubMed)

Sato 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.

Reference Type: BACKGROUND

PMID: 25788204 (View on PubMed)

Brenner 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.

Reference Type: BACKGROUND

PMID: 23632815 (View on PubMed)

Other Identifiers

SDCHI-HDN

Identifier Type: -

Identifier Source: org_study_id