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Evaluation of Outcomes From Treatment of Benign or Malignant Pancreatic Diseases

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ClinicalTrials.gov Identifier: NCT04055571
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Brief Summary:
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.

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Outcomes From Treatment of Benign or Malignant Pancreatic Diseases
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : January 30, 2025
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2005 to 2019 ]
    Number of patients who have been diagnosed with benign or malignant pancreatic disease

  2. Mortality [ Time Frame: 2005 to 2019 ]
    Number of patients who have been diagnosed with benign or malignant pancreatic disease

  3. Morbidity [ Time Frame: 2005 to 2019 ]
    Number of patients who have been diagnosed with benign or malignant pancreatic disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055571


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1280 CrysteeCooper@mhd.com
Contact: Nitasha Phatak, Ph.D. 214-947-4459 NitashaPhatak@mhd.com

Locations
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United States, Texas
Trinity Surgical Consultants, Methodist Richardson Medical Center Recruiting
Richardson, Texas, United States, 75082
Contact: Dhiresh R Jeyarajah, MD    972-619-3500      
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Dhiresh Jeyarajah, M.D. Methodist Richardson Medical Center

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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04055571     History of Changes
Other Study ID Numbers: 036.HPB.2018.R
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only de-identified PHI will be shared in relevant research mediums.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases