Outcomes From Treatment Liver and Bile Duct Diseases

Active, not recruiting

• Conditions: Benign or Malignant Liver and Bile Duct Disease

• Registration Number: NCT04637243
• Lead Sponsor: Methodist Health System

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Status Verified: 2023-03
• Study Start: 2023-03-09
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality from Treatment of Benign or Malignant Liver and Bile Duct Diseases	2005 to 2019	Mortality
Morbidity from Treatment of Benign or Malignant Liver and Bile Duct Diseases	2005 to 2019	Morbidity

Trial Locations

Locations (1)

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