Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients

Not Applicable

Completed

• Conditions: Liver Cancer; Liver Cirrhosis
• Interventions: Device: Radioactive Seed Implantation

• Registration Number: NCT05989789
• Lead Sponsor: Clarunis - Universitäres Bauchzentrum Basel

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.

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2021-03-27
• Study Completion: 2021-06-30
• Study First Submitted: 2023-06-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

• suspect cancerous liver lesion
• fit for surgery

Exclusion Criteria

• emergency surgery
• age under 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients	Radioactive Seed Implantation	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

Primary Outcome Measures

Name	Time	Method
Procedure-Safety (No residual source of radiation)	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.
R0-Resection according to the tumour classification system	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients without side effects	6 months	Clinical follow up of the patients to ensure that there are no side effects from implanting the Seed in the liver

Trial Locations

Locations (1)

University hospital; 🇨🇭 Basel, Switzerland