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NCT Number: NCT05989789

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

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Fibrosis Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University hospital

Basel, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suspect cancerous liver lesion
  • fit for surgery

Exclusion criteria

  • emergency surgery
  • age under 18

Treatment and study plan

Radioactive Seed Implantation

Device

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 outcomes

  1. R0-Resection according to the tumour classification system

    Time frame: 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)

    Time frame: 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 outcomes

  1. Number of patients without side effects

    Time frame: 6 months

    Clinical follow up of the patients to ensure that there are no side effects from implanting the Seed in the liver

Sponsors and collaborators

Lead sponsor

Clarunis - Universitäres Bauchzentrum Basel

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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