Trial record 139 of 350 for:    hepatitis b | Open Studies

Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2016 by Shandong Cancer Hospital and Institute
Sponsor:
Information provided by (Responsible Party):
Lei ZHAO, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT02793791
First received: May 31, 2016
Last updated: June 2, 2016
Last verified: June 2016
  Purpose
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 Intervention
Dysplastic Nodule of Liver
Chronic Hepatitis B
Procedure: minimally invasive ablation therapies

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 30
Study Start Date: September 2016
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ablation Procedure: minimally invasive ablation therapies
Including RFA (radiofrequency ablation);MWA (microwave ablation); PEI (percutaneous ethanol injection),etc.
No Intervention: Observation

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • concurrent HCV infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02793791

Contacts
Contact: Lei Zhao, MD +8653167626368 drzhaolei@hotmail.com

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

Publications:
Responsible Party: Lei ZHAO, Doctor; Director, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02793791     History of Changes
Other Study ID Numbers: SDCHI-HDN 
Study First Received: May 31, 2016
Last Updated: June 2, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Shandong Cancer Hospital and Institute:
high grade dysplastic nodule (HGDN)
low grade dysplastic nodule (LGDN)

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hyperplasia
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 19, 2017