Evaluation of Outcomes From Treatment of Benign or Malignant Pancreatic Diseases

This study will be a retrospective chart review of patients who have been diagnosed with the benign or malignant pancreatic disease under the practice of Dr. Rohan Jeyarajah, M.D., Dr. Houssam Osman M.D., and Dr. Edward Cho M.D., Sc.M. at Methodist Health System Hospital in Richardson, TX. The investigators plan to conduct an analysis of patients meeting the inclusion criteria from 2005 to present. Study will also be conducted by the PI, Sub-Is, surgery fellows, office staff and clinical research coordinator who are delegated to do by the PI. Data will be obtained by looking through either investigator's patients or through a national database. Data will be analyzed primarily by the study conductors.

Study Overview

• Status: Recruiting
• Conditions: Benign or Malignant Pancreatic Diseases

Detailed Description

It is reported in the literature that the treatment of any pancreatic 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. The investigator's 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 the investigator's decisions on multiple treatments of benign or malignant pancreatic diseases.There is a need to understand and improve the current diagnosis and treatment algorithm for pancreatic pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.

All past patients who were treated for a particular benign or malignant pancreatic disease process under evaluation from 2005 to present will be included in this study.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Nitasha Phatak, Ph.D.; Phone Number: 214-947-4459; Email: NitashaPhatak@mhd.com
• Study Contact Backup: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: CrysteeCooper@mhd.com

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75082
      • Recruiting
      • Trinity Surgical Consultants, Methodist Richardson Medical Center
      • Contact: Dhiresh R Jeyarajah, MD; Phone Number: 972-619-3500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All past patients who were treated for a particular benign or malignant pancreatic disease process under evaluation from 2005 to present will be included in this study.

Description

Inclusion Criteria:

• • All patients diagnosed and treated for pancreatic diseases, benign or malignant from 2005 to present

  • Age ≥18 years

Exclusion Criteria:

• • Patients that are not diagnosed with or treated for pancreatic diseases

  • Age < 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Number of patients who have been diagnosed with benign or malignant pancreatic disease	2005 to 2019

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Dhiresh Jeyarajah, M.D., Methodist Richardson Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 036.HPB.2018.R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only de-identified PHI will be shared in relevant research mediums.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No