Hepatocellular CarcinomaNCT05545046
Predictive Model for Pain After TACE
An observational study of Hepatocellular Carcinoma, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial summary
The main aim of this study was to analyze the risk factors that helped to predict the pain after transarterial chemoembolization (TACE).This was a prospective observational study enrolled all hepatocellular carcinoma (HCC) patients undergoing TACE in our hospital. Read more about this study
- Who is it for?
- Ages 34 to 87 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Jan 2021
- How long will I take part?
- 16 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 34 to 87 years
- All sexes
- Adult, Older adult
Study population: A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.
Who may be able to join
- A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.
Who cannot join
- patients aged < 18 year
- significant heart or lung dysfunction
- use of additional analgesics to relieve pain during TACE
- cognitive impairment
- use of psychiatric medications
- drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Predictive Model for Pain After Transarterial Chemoembolization
The main aim of this study was to analyze the risk factors that helped to predict the pain after transarterial chemoembolization (TACE).This was a prospective observational study enrolled all hepatocellular carcinoma (HCC) patients undergoing TACE in our hospital. Pain score at rest was assessed after TACE by the patients themselves using a Visual Analogue Scale (VAS). Independent variables such as age, gender, tumor location, tumor size and number, drug delivery method and presence of portal vein tumor thrombosis (PVTT) were recorded and analyzed.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Measured: 0 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Measured: 2 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Measured: 4 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Measured: 6 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Measured: 12 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Measured: 24 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Sep 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545046
- Sponsor's protocol ID
- 2019-406
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Model for Pain After Transarterial Chemoembolization
- ClinicalTrials.gov ID
- NCT05545046
- Acronym / sponsor ID
- 2019-406
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 19 Sep 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.
The main aim of this study was to analyze the risk factors that helped to predict the pain after transarterial chemoembolization (TACE).This was a prospective observational study enrolled all hepatocellular carcinoma (HCC) patients undergoing TACE in our hospital. Pain score at rest was assessed after TACE by the patients themselves using a Visual Analogue Scale (VAS). Independent variables such as age, gender, tumor location, tumor size and number, drug delivery method and presence of portal vein tumor thrombosis (PVTT) were recorded and analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 16 Months
Who may qualify
- Ages
- 34 to 87 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.
Key inclusion criteria (1 listed)
- A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.
Key exclusion criteria (6 listed)
- patients aged < 18 year
- significant heart or lung dysfunction
- use of additional analgesics to relieve pain during TACE
- cognitive impairment
- use of psychiatric medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 0 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Visual Analogue Scale (VAS)
Time frame: 2 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Visual Analogue Scale (VAS)
Time frame: 4 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Visual Analogue Scale (VAS)
Time frame: 6 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Visual Analogue Scale (VAS)
Time frame: 12 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Visual Analogue Scale (VAS)
Time frame: 24 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)
After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Yantai Yuhuangding 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 19 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 0 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)). The study lists 6 primary outcomes in all. 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 19 Sep 2022.