Evaluation of Outcomes From Treatment of Benign or Malignant Pancreatic Diseases
Evaluation of Outcomes From Treatment of Benign or Malignant Pancreatic Diseases
Sponsors
Source
Methodist Health System
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
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.
Overall Status
Recruiting
Start Date
2019-03-05
Completion Date
2025-01-30
Primary Completion Date
2025-01-30
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Overall survival |
2005 to 2019 |
|
Mortality |
2005 to 2019 |
|
Morbidity |
2005 to 2019 |
Enrollment
500
Condition
Eligibility
Study Pop
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.
Sampling Method
Probability Sample
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Dhiresh Jeyarajah, M.D. |
Principal Investigator |
Methodist Richardson Medical Center |
Overall Contact
Location
Facility |
Status |
Contact |
|
Trinity Surgical Consultants, Methodist Richardson Medical Center Richardson Texas 75082 United States |
Recruiting |
Last Name: Dhiresh R Jeyarajah, MD Phone: 972-619-3500 |
Location Countries
Country
United States
Verification Date
2019-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Overall Contact Backup
Patient Data
Sharing Ipd
Yes
Ipd Description
Only de-identified PHI will be shared in relevant research mediums.
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Retrospective
Study First Submitted
March 22, 2019
Study First Submitted Qc
August 12, 2019
Study First Posted
August 13, 2019
Last Update Submitted
August 12, 2019
Last Update Submitted Qc
August 12, 2019
Last Update Posted
August 13, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.