Back to resultsCT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection (CTMH)
Primary Purpose
Cirrhosis, Liver, Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CT-guided localization for micro hepatocellular carcinoma before surgical resection
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Cirrhosis, hepatocellular carcinoma, localization needle
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years old and give informed consent to participate in the study
- A preoperative (clinical, radiological, or histological) diagnosis of cirrhosis of the liver due to any cause.
- micro hepatocellular carcinoma (diameter less than 1cm).
- Preoperative CT plain scan could not find the lesion, and preoperative B-ultrasound could not find the lesion.
- Preoperative CT enhancement or MRI can detect the lesion.
Exclusion Criteria:
- Child-Pugh grade C
- Uncontrolled Hypertension
- Severe lung dysfunction
- Severe cardiac dysfunction
Sites / Locations
- Clinical Medical College, Yangzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT-guided localization for micro hepatocellular carcinoma before surgical resection
Arm Description
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.
Outcomes
Primary Outcome Measures
The position of the needle
The distance (mm) of the needle to the edge of hepatocellular carcinoma
Secondary Outcome Measures
Operation time
The length of operation time (min)
Intraoperative bleeding
The volume of intraoperative bleeding (ml)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05433467
Brief Title
CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
Acronym
CTMH
Official Title
The Feasibility of CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Hepatocellular Carcinoma
Keywords
Cirrhosis, hepatocellular carcinoma, localization needle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-guided localization for micro hepatocellular carcinoma before surgical resection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
CT-guided localization for micro hepatocellular carcinoma before surgical resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
The position of the needle
Description
The distance (mm) of the needle to the edge of hepatocellular carcinoma
Time Frame
During operation
Secondary Outcome Measure Information:
Title
Operation time
Description
The length of operation time (min)
Time Frame
During operation
Title
Intraoperative bleeding
Description
The volume of intraoperative bleeding (ml)
Time Frame
During operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years old and give informed consent to participate in the study
A preoperative (clinical, radiological, or histological) diagnosis of cirrhosis of the liver due to any cause.
micro hepatocellular carcinoma (diameter less than 1cm).
Preoperative CT plain scan could not find the lesion, and preoperative B-ultrasound could not find the lesion.
Preoperative CT enhancement or MRI can detect the lesion.
Exclusion Criteria:
Child-Pugh grade C
Uncontrolled Hypertension
Severe lung dysfunction
Severe cardiac dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-Qing Jiang, MD
Phone
+8651487373382
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dou-Sheng Bai, MD
Phone
+8651487373382
Email
jgqing2003@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Organizational Affiliation
Clinical Medical College, Yangzhou University
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Medical College, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Phone
86-514-87373372
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dou-Sheng Bai, MD
Phone
86-514-87373372
Email
bdsno1@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
First Name & Middle Initial & Last Name & Degree
Tian-Ming Gao, MD
12. IPD Sharing Statement
Learn more about this trial
CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
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