Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients

NCT05989789 | Completed

• 1 other identifier: 2019_02118
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of patients without side effects

  6 months

Study Arms (1)

Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients

OTHER

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

Interventions

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.

Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suspect cancerous liver lesion
• fit for surgery

You may not qualify if:

• emergency surgery
• age under 18

Sponsors & Collaborators

• Clarunis - Universitäres Bauchzentrum Basel: lead

Study Sites (1)

University hospital

Basel, Switzerland

Location

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Savas D Soysal, Professor

  Clarunis Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 14, 2023
• Study Start: June 15, 2020
• Primary Completion: March 27, 2021
• Study Completion: June 30, 2021
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

CH (1)