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Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients

Primary Purpose

Liver Cancer, Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Radioactive Seed Implantation
Sponsored by
Clarunis - Universitäres Bauchzentrum Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: suspect cancerous liver lesion fit for surgery Exclusion Criteria: emergency surgery age under 18

Sites / Locations

  • University hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2023
Last Updated
August 9, 2023
Sponsor
Clarunis - Universitäres Bauchzentrum Basel
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1. Study Identification

Unique Protocol Identification Number
NCT05989789
Brief Title
Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients
Official Title
Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
March 27, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clarunis - Universitäres Bauchzentrum Basel

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Liver Cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Radioactive Seed Implantation
Intervention Description
In patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde.
Primary Outcome Measure Information:
Title
R0-Resection according to the tumour classification system
Description
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.
Time Frame
1 week after operation
Title
Procedure-Safety (No residual source of radiation)
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Number of patients without side effects
Description
Clinical follow up of the patients to ensure that there are no side effects from implanting the Seed in the liver
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspect cancerous liver lesion fit for surgery Exclusion Criteria: emergency surgery age under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savas D Soysal, Professor
Organizational Affiliation
Clarunis Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients

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