Liver CancerNCT05989789
Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients
A study testing Radioactive Seed Implantation in people with Liver Cancer and Liver Cirrhosis, run by Clarunis - Universitäres Bauchzentrum Basel at 1 site in Switzerland.
Trial summary
Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Liver Cancer, Liver Cirrhosis
- What is being tested?
- Radioactive Seed Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2020to 30 Jun 2021
- Phase
- Interventional
- 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspect cancerous liver lesion
- fit for surgery
Who cannot join
- emergency surgery
- age under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases
Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach. The investigators present two cases of cirrhotic patients where this method of tumor labelling was used.
Read the detailed description
The investigators selected two cases of patients with liver cirrhosis where seed-guided liver resection was used. Seed-guided resection is procedure that is usually commonly used in breast cancer surgery but so far not in liver surgery.
This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques.
The first case was a patient suffering from suspected hepatocellular carcinoma with the background of alcoholic liver cirrhosis. This patient already underwent liver surgery to remove the suspected tumour but the lesion could not be removed correctly as identification was not possible neither with palpation nor with the help of intraoperative ultrasound. For this reason, the patient was selected for seed-guided resection.
The second patient, who presented nine months after the first one, presented with the suspicion of cirrhosis, two lesion small in size and in a surgically difficult localization. Therefore, the patient was selected for seed-guided resection.
- Conditions
- Liver Cancer, Liver Cirrhosis
- Being tested
- Radioactive Seed Implantation
- Medical subject headings
- Liver Neoplasms, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive Seed ImplantationDevice
In patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde.
| Study group | Role | What they receive |
|---|---|---|
| Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients | Other | Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach.
This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques. It also highlights the successful adaption of a procedure commonly used for breast cancer surgery for liver surgery Receives: Device: Radioactive Seed Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0-Resection according to the tumour classification system
Removal of the tumour in healthy tissue, which means that microscopically no tumour tissue is detectable in the resection margin of the removed tissue.
This is always examined by a trained pathologist.
Measured: 1 week after operation
Procedure-Safety (No residual source of radiation)
Complete seed extraction was confirmed intraoperatively by specimen radiography immediately after tissue removal and by ensuring that no residual source of radiation is traceable in the patient with the gamma probe system.
Measured: 1 Day
Secondary outcomes (1)
Number of patients without side effects
Clinical follow up of the patients to ensure that there are no side effects from implanting the Seed in the liver
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Jun 2020
- Primary completion27 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarunis - Universitäres Bauchzentrum Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savas Soysal, Clarunis - Universitäres Bauchzentrum Basel
- Investigators
- Savas D Soysal, Professor, Principal investigator, Clarunis Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989789
- Sponsor's protocol ID
- 2019_02118
- Other IDs
- 2019
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2023
- Last updated
- 14 Aug 2023
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases
- ClinicalTrials.gov ID
- NCT05989789
- Acronym / sponsor ID
- 2019_02118
- Conditions
- Liver Cancer, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Clarunis - Universitäres Bauchzentrum BaselUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Aug 2023 (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.
Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach. The investigators present two cases of cirrhotic patients where this method of tumor labelling was used.
Detailed description
The investigators selected two cases of patients with liver cirrhosis where seed-guided liver resection was used. Seed-guided resection is procedure that is usually commonly used in breast cancer surgery but so far not in liver surgery.
This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques.
The first case was a patient suffering from suspected hepatocellular carcinoma with the background of alcoholic liver cirrhosis. This patient already underwent liver surgery to remove the suspected tumour but the lesion could not be removed correctly as identification was not possible neither with palpation nor with the help of intraoperative ultrasound. For this reason, the patient was selected for seed-guided resection.
The second patient, who presented nine months after the first one, presented with the suspicion of cirrhosis, two lesion small in size and in a surgically difficult localization. Therefore, the patient was selected for seed-guided resection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients | Other | Device: Radioactive Seed ImplantationDetection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach. This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques. It also highlights the successful adaption of a procedure commonly used for breast cancer surgery for liver surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suspect cancerous liver lesion
- fit for surgery
Key exclusion criteria (2 listed)
- emergency surgery
- age under 18
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 |
|---|---|---|
| Radioactive Seed ImplantationIn patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde. | Device | Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients |
Primary outcome
R0-Resection according to the tumour classification system
Time frame: 1 week after operation
Removal of the tumour in healthy tissue, which means that microscopically no tumour tissue is detectable in the resection margin of the removed tissue. This is always examined by a trained pathologist.
Procedure-Safety (No residual source of radiation)
Time frame: 1 Day
Complete seed extraction was confirmed intraoperatively by specimen radiography immediately after tissue removal and by ensuring that no residual source of radiation is traceable in the patient with the gamma probe system.
1 secondary outcome
Number of patients without side effects
Time frame: 6 months
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 14 Aug 2023.
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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.
Savas D Soysal, Professor principal investigator
Clarunis Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radioactive Seed Implantation in people with Liver Cancer and Liver Cirrhosis, run by Clarunis - Universitäres Bauchzentrum Basel at 1 site in Switzerland.
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 2 inclusion and 2 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 14 Aug 2023. 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 Switzerland. 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?
R0-Resection according to the tumour classification system (time frame: 1 week after operation). The study lists 2 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 14 Aug 2023.