Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05989789
• Other study ID #: 2019_02118
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2023
• Source: Clarunis - Universitäres Bauchzentrum Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators present two cases of cirrhotic patients where this method of tumor labelling was used.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 30, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• suspect cancerous liver lesion
• fit for surgery

Exclusion Criteria:

• emergency surgery
• age under 18

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Liver Cancer
• Liver Cirrhosis

Intervention

Device:
• Radioactive 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.

Locations

Country	Name	City	State
Switzerland	University hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Clarunis - Universitäres Bauchzentrum Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week after operation
Primary	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.	1 Day
Secondary	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	6 months