Cirrhosis, LiverCTMHNCT05433467
CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
A study testing CT-guided localization for micro hepatocellular carcinoma before surgical resection in people with Cirrhosis, Liver and Hepatocellular Carcinoma, run by Northern Jiangsu People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Hepatocellular Carcinoma
- What is being tested?
- CT-guided localization for micro hepatocellular carcinoma before surgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Child-Pugh grade C
- Uncontrolled Hypertension
- Severe lung dysfunction
- Severe cardiac dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Clinical Medical College, Yangzhou University
Yangzhou, Jiangsu, 225001
Guo-Qing Jiang, MD, 86-514-87373372, jgqing2003@hotmail.com
Dou-Sheng Bai, MD, 86-514-87373372, bdsno1@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cirrhosis, Liver, Hepatocellular Carcinoma
- Being tested
- CT-guided localization for micro hepatocellular carcinoma before surgical resection
- Keywords
- Cirrhosis, hepatocellular carcinoma, localization needle
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided localization for micro hepatocellular carcinoma before surgical resectionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CT-guided localization for micro hepatocellular carcinoma before surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The position of the needle
The distance (mm) of the needle to the edge of hepatocellular carcinoma
Measured: During operation
Secondary outcomes (2)
Operation time
The length of operation time (min)
Measured: During operation
Intraoperative bleeding
The volume of intraoperative bleeding (ml)
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 May 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- Guo-Qing Jiang, MD, Study chair, Clinical Medical College, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433467
- Sponsor's protocol ID
- YZUC-012
- Acronym
- CTMH
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2022
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
- ClinicalTrials.gov ID
- NCT05433467
- Acronym / sponsor ID
- CTMH / YZUC-012
- Conditions
- Cirrhosis, Liver, Hepatocellular Carcinoma
- Keywords
- Cirrhosis, hepatocellular carcinoma, localization needle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-guided localization for micro hepatocellular carcinoma before surgical resection | Experimental | Procedure: CT-guided localization for micro hepatocellular carcinoma before surgical resectionfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Child-Pugh grade C
- Uncontrolled Hypertension
- Severe lung dysfunction
- Severe cardiac dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided localization for micro hepatocellular carcinoma before surgical resectionAfter 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 or surgery | CT-guided localization for micro hepatocellular carcinoma before surgical resection |
Primary outcome
The position of the needle
Time frame: During operation
The distance (mm) of the needle to the edge of hepatocellular carcinoma
2 secondary outcomes
Operation time
Time frame: During operation
Intraoperative bleeding
Time frame: During operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guo-Qing Jiang, MD study chair
Clinical Medical College, Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided localization for micro hepatocellular carcinoma before surgical resection in people with Cirrhosis, Liver and Hepatocellular Carcinoma, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo-Qing Jiang, MD (+8651487373382, jgqing2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The position of the needle (time frame: During operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.