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临床试验/NCT05989789
NCT05989789已完成不适用

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

Clarunis - Universitäres Bauchzentrum Basel1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2
试验地点
1
主要终点
Procedure-Safety (No residual source of radiation)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • suspect cancerous liver lesion
  • fit for surgery

排除标准

  • emergency surgery
  • age under 18

结局指标

主要结局

Procedure-Safety (No residual source of radiation)

时间窗: 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

时间窗: 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.

次要结局

  • Number of patients without side effects(6 months)

研究者

发起方
Clarunis - Universitäres Bauchzentrum Basel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Savas Soysal

Principal Investigator

Clarunis - Universitäres Bauchzentrum Basel

研究点 (1)

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