NCT05433467

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

June 21, 2022

Last Update Submit

August 7, 2025

Conditions

Cirrhosis, LiverHepatocellular Carcinoma

Keywords

Cirrhosishepatocellular carcinomalocalization needle

Outcome Measures

Primary Outcomes (1)

  • The position of the needle

    The distance (mm) of the needle to the edge of hepatocellular carcinoma

    During operation

Secondary Outcomes (2)

  • Operation time

    During operation

  • Intraoperative bleeding

    During operation

Study Arms (1)

CT-guided localization for micro hepatocellular carcinoma before surgical resection

EXPERIMENTAL

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

Interventions

CT-guided localization for micro hepatocellular carcinoma before surgical resectionPROCEDURE

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.

CT-guided localization for micro hepatocellular carcinoma before surgical resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Child-Pugh grade C
  • Uncontrolled Hypertension
  • Severe lung dysfunction
  • Severe cardiac dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, HepatocellularFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Guo-Qing Jiang, MD

    Clinical Medical College, Yangzhou University

    STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang, MD

CONTACT

+8651487373382jgqing2003@hotmail.com

Dou-Sheng Bai, MD

CONTACT

+8651487373382jgqing2003@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

May 1, 2022

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations

CN(1)