Pancreatic Malignant Neoplasm PrimaryNCT04637256
Evaluation of Outcomes From Treatment of Benign or Malignant Gastroesophageal Diseases
An observational study of Pancreatic Malignant Neoplasm Primary, run by Methodist Health System at 1 site in United States.
Trial summary
This study will be a retrospective chart review of patients who have been diagnosed with 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, Texas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Malignant Neoplasm Primary
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All past patients who were treated for a particular benign or malignant gastroesophageal disease process under evaluation from 2005 to present will be included in this study.
Who may be able to join
- All patients diagnosed and treated for gastroesophageal diseases, benign or malignant from 2005 to present.
- Age ≥18 years
Who cannot join
- Patients that are not diagnosed with or treated for gastroesophageal diseases
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Trinity Surgical Consultants, Methodist Richardson Medical Center
Richardson, Texas, 75082
About this study
This study will be a retrospective chart review of patients who have been diagnosed with 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, Texas. 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 the investigator's patients from their practice or through a national database. Data will be analyzed primarily by the study conductors.
Read the detailed description
- INTRODUCTION 1.1. Background It is reported in the literature that the treatment of any gastroesophageal disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with esophageal cancer 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 Primary investigtor goal is to continue to review patient treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity. 1.2. Aim(s)/Objective(s) The main aim of this study is to evaluate and compare the outcomes from the investigator's treatment of benign or gastroesophageal diseases. 1.3. Rationale for the study There is a need to understand and improve the current diagnosis and treatment algorithm for gastroesophageal pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.
- OBJECTIVES AND STUDY OUTCOME MEASURES 2.1. Study Objectives 2.1.1. Primary Objective(s)
- To evaluate and compare the outcomes from the investigator's treatment of benign or malignant gastroesophageal disease 2.2. Study Outcome Measures 2.2.1. Primary Outcome(s)
- To exam all treatments of benign or malignant gastroesophageal disease by measuring the following outcomes
- Overall survival
- Overall symptom control
- Mortality
- Morbidity
- STUDY ENROLLMENT AND WITHDRAWAL 4.1. Study Inclusion Criteria:
- All patients diagnosed and treated for gastroesophageal diseases, benign or malignant from 2005 to present.
- Age ≥18 years 4.2. Study Exclusion Criteria:
- Patients that are not diagnosed with or treated for gastroesophageal diseases
- Age < 18 years 5. STATISTICAL CONSIDERATIONS 5.1. Sample Size Considerations All past patients who were treated for a particular benign or malignant gastroesophageal disease process under evaluation from 2005 to present will be included in this study.
5.2. Statistical Analysis Plan Statistics will be provided for all data obtained. Normally distributed continuous outcomes will be analyzed with Student's t test and non-normally distributed continuous outcomes will be analyzed with nonparametric Wilcoxon-Mann-Whitney test. Categorical outcomes will be analyzed using chi-square test or Fisher's exact test for smaller samples.
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- Conditions
- Pancreatic Malignant Neoplasm Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
We will be examining all treatments of benign or malignant pancreatic cancer by measuring the following outcome: overall survival
Measured: 2005 to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start6 Mar 2019
- Primary completion27 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Malignant Neoplasm PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhiresh Jeyarajah, M.D., Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637256
- Sponsor's protocol ID
- 037.HPB.2018.R
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Outcomes From Treatment of Benign or Malignant Gastroesophageal Diseases
- ClinicalTrials.gov ID
- NCT04637256
- Acronym / sponsor ID
- 037.HPB.2018.R
- Conditions
- Pancreatic Malignant Neoplasm Primary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a retrospective chart review of patients who have been diagnosed with 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, Texas. 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 the investigator's patients from their practice or through a national database. Data will be analyzed primarily by the study conductors.
Detailed description
- INTRODUCTION 1.1. Background It is reported in the literature that the treatment of any gastroesophageal disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with esophageal cancer 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 Primary investigtor goal is to continue to review patient treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity. 1.2. Aim(s)/Objective(s) The main aim of this study is to evaluate and compare the outcomes from the investigator's treatment of benign or gastroesophageal diseases. 1.3. Rationale for the study There is a need to understand and improve the current diagnosis and treatment algorithm for gastroesophageal pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.
- OBJECTIVES AND STUDY OUTCOME MEASURES 2.1. Study Objectives 2.1.1. Primary Objective(s)
- To evaluate and compare the outcomes from the investigator's treatment of benign or malignant gastroesophageal disease 2.2. Study Outcome Measures 2.2.1. Primary Outcome(s)
- To exam all treatments of benign or malignant gastroesophageal disease by measuring the following outcomes
- Overall survival
- Overall symptom control
- Mortality
- Morbidity
- STUDY ENROLLMENT AND WITHDRAWAL 4.1. Study Inclusion Criteria:
- All patients diagnosed and treated for gastroesophageal diseases, benign or malignant from 2005 to present.
- Age ≥18 years 4.2. Study Exclusion Criteria:
- Patients that are not diagnosed with or treated for gastroesophageal diseases
- Age < 18 years 5. STATISTICAL CONSIDERATIONS 5.1. Sample Size Considerations All past patients who were treated for a particular benign or malignant gastroesophageal disease process under evaluation from 2005 to present will be included in this study.
5.2. Statistical Analysis Plan Statistics will be provided for all data obtained. Normally distributed continuous outcomes will be analyzed with Student's t test and non-normally distributed continuous outcomes will be analyzed with nonparametric Wilcoxon-Mann-Whitney test. Categorical outcomes will be analyzed using chi-square test or Fisher's exact test for smaller samples.
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Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All past patients who were treated for a particular benign or malignant gastroesophageal disease process under evaluation from 2005 to present will be included in this study.
Key inclusion criteria (2 listed)
- All patients diagnosed and treated for gastroesophageal diseases, benign or malignant from 2005 to present.
- Age ≥18 years
Key exclusion criteria (2 listed)
- Patients that are not diagnosed with or treated for gastroesophageal diseases
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: 2005 to 2019
We will be examining all treatments of benign or malignant pancreatic cancer by measuring the following outcome: overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhiresh Jeyarajah, M.D. principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Malignant Neoplasm Primary, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2005 to 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.