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Hepatic Arteriography in Liver Cancer Diagnosis and Staging Applications (RDSA)

Primary Purpose

HepatoCellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hepatic Arteriography
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HepatoCellular Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with primary liver cancer who is firstly diagnosed in Affiliated Tumor Hospital of Guangxi Medical University after November 2015, and the clinical diagnostic criteria is according to China's "primary liver cancer diagnostic and treatment practices (2011)". Clinical diagnostic criteria: In all solid tumors, there is only hepatocellular carcinoma can use clinical diagnostic criteria, which is recognized by domestic and foreign countries. Combined with China's national conditions, history of the national standards and clinical practice, the Expert Group can establish the clinical diagnosis of hepatocellular carcinoma requested the following conditions 1 + 2a or 1 + 2b + 3 at the same time satisfy:

    • Patients have evidence of liver cirrhosis or HBV and / or HCV infection (HBV and / or HCV antigen positive).
    • Typical imaging features of hepatocellular carcinoma: liver lesion shows arterial hypervascularity and venous or delayed phase washout in multidetector CT scan and / or dynamic contrast enhanced MRI. a: If the liver lesion diameter≥2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in one of the imaging methods. b: If the liver lesion diameter is between 1 to 2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in both of the imaging methods.
    • Serum AFP≥400μg/L for 1 month or ≥200μg/L for 2 month, and can rule out other causes of AFP increasing (pregnancy, reproductive system embryo-derived tumors, active liver disease and secondary liver cancer, etc.).

Exclusion Criteria:

  • Patients do not conform to China's "primary liver cancer diagnostic and treatment practices (2011)".
  • Patients allergic to Iodine-containing contrast agents or with obvious hyperthyroidism.
  • Patients with severe cardiovascular disease or liver or renal insufficiency, who do not tolerate digital subtraction angiography or will significantly increase the risk of diseases.
  • Patients have severe coagulation disorders or are extreme weak.
  • Patients have fever or have infection on the puncture site.
  • Patients suffer from mental illness or cannot cooperate with the treatment.

Sites / Locations

  • TaoBaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

After Hepatic Arteriography

Before Hepatic Arteriography

Arm Description

Outcomes

Primary Outcome Measures

Detection of numbers of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Comparing the numbers and distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies

Secondary Outcome Measures

Detection of distribution of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Comparing the distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies

Full Information

First Posted
May 10, 2016
Last Updated
February 23, 2017
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02936856
Brief Title
Hepatic Arteriography in Liver Cancer Diagnosis and Staging Applications
Acronym
RDSA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

5. Study Description

Brief Summary
Primary liver cancer is one of the most common malignant tumor and leading cause of cancer-related death worldwide. Basically therapeutic strategies were considered and given based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and distribution of malignant lesions were extreme important. Enhanced CT or MRI is routinely imaging scans to detect and identify lesions. Unfortunately, some malignant lesions usually presented untypical imaging characteristics, especially among lesions no larger than 1 cm, which misleading to the exact staging of liver cancer and the optimal therapeutic strategies. Basically most of blood supply for malignant liver tumors is from the hepatic artery. Based on this fact, hepatic arterial digital subtraction angiography could potentially elevate the accuracy and sensitivity of detection malignant lesions numbers and distribution. In this study the investigators will compare the numbers and distribution of malignant lesions before and after hepatic arteriography, then to revise the staging of liver cancer and to provide better therapeutic strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HepatoCellular Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
After Hepatic Arteriography
Arm Type
Experimental
Arm Title
Before Hepatic Arteriography
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hepatic Arteriography
Primary Outcome Measure Information:
Title
Detection of numbers of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Description
Comparing the numbers and distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Detection of distribution of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Description
Comparing the distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with primary liver cancer who is firstly diagnosed in Affiliated Tumor Hospital of Guangxi Medical University after November 2015, and the clinical diagnostic criteria is according to China's "primary liver cancer diagnostic and treatment practices (2011)". Clinical diagnostic criteria: In all solid tumors, there is only hepatocellular carcinoma can use clinical diagnostic criteria, which is recognized by domestic and foreign countries. Combined with China's national conditions, history of the national standards and clinical practice, the Expert Group can establish the clinical diagnosis of hepatocellular carcinoma requested the following conditions 1 + 2a or 1 + 2b + 3 at the same time satisfy: Patients have evidence of liver cirrhosis or HBV and / or HCV infection (HBV and / or HCV antigen positive). Typical imaging features of hepatocellular carcinoma: liver lesion shows arterial hypervascularity and venous or delayed phase washout in multidetector CT scan and / or dynamic contrast enhanced MRI. a: If the liver lesion diameter≥2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in one of the imaging methods. b: If the liver lesion diameter is between 1 to 2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in both of the imaging methods. Serum AFP≥400μg/L for 1 month or ≥200μg/L for 2 month, and can rule out other causes of AFP increasing (pregnancy, reproductive system embryo-derived tumors, active liver disease and secondary liver cancer, etc.). Exclusion Criteria: Patients do not conform to China's "primary liver cancer diagnostic and treatment practices (2011)". Patients allergic to Iodine-containing contrast agents or with obvious hyperthyroidism. Patients with severe cardiovascular disease or liver or renal insufficiency, who do not tolerate digital subtraction angiography or will significantly increase the risk of diseases. Patients have severe coagulation disorders or are extreme weak. Patients have fever or have infection on the puncture site. Patients suffer from mental illness or cannot cooperate with the treatment.
Facility Information:
Facility Name
TaoBai
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bai Tao, MD
Phone
+86 13878862632
Email
25859373@qq.com

12. IPD Sharing Statement

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Hepatic Arteriography in Liver Cancer Diagnosis and Staging Applications

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