CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection

Hepatocellular Carcinoma Clinical Trial

— CTMH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433467
• Other study ID #: YZUC-012
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Northern Jiangsu People's Hospital
• Contact: Guo-Qing Jiang, MD
• Phone: +8651487373382
• Email: jgqing2003[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis, Liver
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
China	Clinical Medical College, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The position of the needle	The distance (mm) of the needle to the edge of hepatocellular carcinoma	During operation
Secondary	Operation time	The length of operation time (min)	During operation
Secondary	Intraoperative bleeding	The volume of intraoperative bleeding (ml)	During operation