Outcomes From Treatment Liver and Bile Duct Diseases

• Sponsor: Methodist Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT04637243
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Actual Duration (Months): 21.7
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign or Malignant Liver and Bile Duct Disease	Other: Treatment 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 Design

• Study Type: Observational
• Actual Enrollment: 126 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Evaluation of Outcomes From Treatment of Benign or Malignant Liver and Bile Duct Diseases
• Actual Study Start Date: May 12, 2019
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Outcome Measures

Primary Outcome Measures

1. Mortality from Treatment of Benign or Malignant Liver and Bile Duct Diseases [2005 to 2019]

   Mortality

2. Morbidity from Treatment of Benign or Malignant Liver and Bile Duct Diseases [2005 to 2019]

   Morbidity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Richardson Medical Center	Richardson	Texas	United States	75082

Sponsors and Collaborators

• Methodist Health System

Investigators

• Principal Investigator: Dhiresh Jeyarajah, M.D., Trinity Surgical Consultants, Methodist Richardson Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Methodist Health System
• ClinicalTrials.gov Identifier: NCT04637243
• Other Study ID Numbers: 035.HPB.2018.R
• First Posted: Nov 19, 2020
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bile Duct Diseases

Study Results

No Results Posted as of Dec 15, 2021