Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients

Sponsor
Clarunis - Universitäres Bauchzentrum Basel (Other)
Overall Status
Completed
CT.gov ID
NCT05989789
Collaborator
(none)
2
1
1
12.5
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Radioactive Seed Implantation
N/A

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

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases
Actual Study Start Date :
Jun 15, 2020
Actual Primary Completion Date :
Mar 27, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • suspect cancerous liver lesion

  • fit for surgery

Exclusion Criteria:
  • emergency surgery

  • age under 18

Contacts and Locations

Locations

Site City State Country Postal Code
1 University hospital Basel Switzerland

Sponsors and Collaborators

  • Clarunis - Universitäres Bauchzentrum Basel

Investigators

  • Principal Investigator: Savas D Soysal, Professor, Clarunis Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Savas Soysal, Principal Investigator, Clarunis - Universitäres Bauchzentrum Basel
ClinicalTrials.gov Identifier:
NCT05989789
Other Study ID Numbers:
  • 2019_02118
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023