Outcomes From Treatment Liver and Bile Duct Diseases

Benign or Malignant Liver and Bile Duct Disease Clinical Trial

Official title:

Evaluation of Outcomes From Treatment of Benign or Malignant Liver and Bile Duct Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04637243
• Other study ID #: 035.HPB.2018.R
• Status: Active, not recruiting
• Start date: March 9, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is reported in the literature that the treatment of any liver and bile duct disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with adenocarcinoma continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. Our goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity. The main aim of this study is to evaluate and compare the outcomes from our multiple treatments of benign or malignant liver and bile duct diseases.

Description:

The study will be a retrospective chart review of patients who have been diagnosed with benign or malignant liver and bile duct disease under the practices of Rohan Jeyarajah, M.D., Houssam Osman, M.D., F.A.C.S., Edward Cho, M.D., Sc.M at Methodist Health System Hospital in Richardson, T.X. We plan to conduct an analysis of patients meeting the inclusion criteria form 2005 to present (up to the day before this study receives IRB approval). Charts will also be reviewed by the PI. Sub-I, Fellows, Office Staff, Clinical Research Coordinator who are delegated to do so by the PI. Data will be obtained from a national database. Data will be analyzed primarily by the study conductors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients diagnosed and treated for liver and bile duct disease benign or malignant from 2005 to present (up to the day before this study receives IRB approval)
• Age > 18 years

Exclusion Criteria:

• Patients that are not diagnosed with or treated for liver and bile duct disease
• Age < 18 years

Related Conditions & MeSH terms

• Benign or Malignant Liver and Bile Duct Disease
• Bile Duct Diseases

Intervention

Other:
• Treatment of Benign or Malignant Liver and Bile Duct Diseases
Available treatment of Benign or Malignant Liver and Bile Duct Diseases

Locations

Country	Name	City	State
United States	Methodist Richardson Medical Center	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality from Treatment of Benign or Malignant Liver and Bile Duct Diseases	Mortality	2005 to 2019
Primary	Morbidity from Treatment of Benign or Malignant Liver and Bile Duct Diseases	Morbidity	2005 to 2019