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

Sponsor

Yangzhou University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05433467

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Liver Hepatocellular Carcinoma	Procedure: CT-guided localization for micro hepatocellular carcinoma before surgical resection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The position of the needle [During operation]
The distance (mm) of the needle to the edge of hepatocellular carcinoma

Secondary Outcome Measures

Operation time [During operation]
The length of operation time (min)
Intraoperative bleeding [During operation]
The volume of intraoperative bleeding (ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.