Treat Primary and Metastatic Liver Tumors

Withdrawn

• Conditions: Liver Tumor; Metastatic Liver Cancer; Metastatic Cancer; Intrahepatic Cholangiocarcinoma

• Registration Number: NCT05240040
• Lead Sponsor: Methodist Health System

Brief Summary

The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.

Detailed Description

A retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. Only patients treated at MDMC are included and data will be obtained from Meditech and Epic. A non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means.

Intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. The standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. Most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. Intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. At MDMC, this therapy has been used effectively and it is important to describe the investigator's experience.

Study Timeline

• Study Start: 2016-04-26
• Study First Submitted: 2019-04-03
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-15
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with the diagnosis of intrahepatic cholangiocarcinoma from January 2006 until April 2017 at Methodist Dallas Medical Center (MDMC)
• Patients 18 years old or older

Exclusion Criteria

• Patients without the diagnosis of intrahepatic cholangiocarcinoma
• Patients under 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
review the outcomes of patients treated with radiospheres	January 2006 until April 2017	Patient survival
time to recurrence	January 2006 until April 2017	time to recurrence

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States