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Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02793791
Recruitment Status : Not yet recruiting
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Information provided by (Responsible Party):
Lei ZHAO, Shandong Cancer Hospital and Institute

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.

Condition or disease Intervention/treatment Phase
Dysplastic Nodule of Liver Chronic Hepatitis B Procedure: minimally invasive ablation therapies Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Minimally-invasive Local Ablation Therapies for the Hepatic Dysplastic Nodules in Patients With Positive Hepatitis B Surface Antigen (HBsAg).
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ablation Procedure: minimally invasive ablation therapies
Including RFA (radiofrequency ablation);MWA (microwave ablation); PEI (percutaneous ethanol injection),etc.

No Intervention: Observation

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • concurrent HCV infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02793791

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Contact: Lei Zhao, MD +8653167626368

Sponsors and Collaborators
Shandong Cancer Hospital and Institute
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Principal Investigator: Lei Zhao, MD Shandong Cancer Hospital and Institute

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Responsible Party: Lei ZHAO, Doctor; Director, Shandong Cancer Hospital and Institute Identifier: NCT02793791     History of Changes
Other Study ID Numbers: SDCHI-HDN
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lei ZHAO, Shandong Cancer Hospital and Institute:
high grade dysplastic nodule (HGDN)
low grade dysplastic nodule (LGDN)
Additional relevant MeSH terms:
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Virus Diseases
DNA Virus Infections
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Hepadnaviridae Infections
Hepatitis, Chronic
Pathologic Processes