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Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients

Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05989789
Enrollment
2
Registered
2023-08-14
Start date
2020-06-15
Completion date
2021-06-30
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Liver Cirrhosis

Brief 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. 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.

Interventions

DEVICERadioactive Seed Implantation

In patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde.

Sponsors

Clarunis - Universitäres Bauchzentrum Basel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* suspect cancerous liver lesion * fit for surgery

Exclusion criteria

* emergency surgery * age under 18

Design outcomes

Primary

MeasureTime frameDescription
R0-Resection according to the tumour classification system1 week after operationRemoval 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)1 DayComplete 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.

Secondary

MeasureTime frameDescription
Number of patients without side effects6 monthsClinical follow up of the patients to ensure that there are no side effects from implanting the Seed in the liver

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026