CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection (CTMH)

August 7, 2025 updated by: Guo-Qing Jiang, Northern Jiangsu People's Hospital

The Feasibility of CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection

In this project, the preoperative anatomical location of micro hepatocellular carcinoma under the guidance of CT can provide guidance for accurate surgical resection. It may also shorten the operation time and reduce intraoperative bleeding.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

General and basic information of the patients included in the study was collected. After preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (Ningbo Sonjiecang Biological Technology Co., LTD., Model: SS510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative CT enhancement or MRI. After the micro hepatocellular carcinoma was located under the guidance of CT, and then the patient was sent to the operating room. During the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Clinical Medical College, Yangzhou University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guo-Qing Jiang, MD
        • Sub-Investigator:
          • Tian-Ming Gao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be at least 18 years old and give informed consent to participate in the study
  2. A preoperative (clinical, radiological, or histological) diagnosis of cirrhosis of the liver due to any cause.
  3. micro hepatocellular carcinoma (diameter less than 1cm).
  4. Preoperative CT plain scan could not find the lesion, and preoperative B-ultrasound could not find the lesion.
  5. Preoperative CT enhancement or MRI can detect the lesion.

Exclusion Criteria:

  1. Child-Pugh grade C
  2. Uncontrolled Hypertension
  3. Severe lung dysfunction
  4. Severe cardiac dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-guided localization for micro hepatocellular carcinoma before surgical resection
fter preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (Ningbo Sonjiecang Biological Technology Co., LTD., Model: SS510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative CT enhancement or MRI. After the micro hepatocellular carcinoma was located under the guidance of CT, and then the patient was sent to the operating room. During the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.
Procedure: CT-guided localization for micro hepatocellular carcinoma before surgical resection
After preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (Ningbo Sonjiecang Biological Technology Co., LTD., Model: SS510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative CT enhancement or MRI. After the micro hepatocellular carcinoma was located under the guidance of CT, and then the patient was sent to the operating room. During the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The position of the needle
Time Frame: During operation
The distance (mm) of the needle to the edge of hepatocellular carcinoma
During operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: During operation
The length of operation time (min)
During operation
Intraoperative bleeding
Time Frame: During operation
The volume of intraoperative bleeding (ml)
During operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu People's Hospital

Investigators

  • Study Chair: Guo-Qing Jiang, MD, Clinical Medical College, Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZUC-012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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