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CompletedNCT04637256Updated Jun 10, 2026

Evaluation of Outcomes From Treatment of Benign or Malignant Gastroesophageal Diseases

An observational study in Pancreatic Malignant Neoplasm Primary, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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. 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
  1. 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.

  2. 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

4. 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 studied

  • Pancreatic Malignant Neoplasm Primary
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In context

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • All patients diagnosed and treated for gastroesophageal diseases, benign or malignant from 2005 to present.
  • Age ≥18 years

Exclusion criteria

Exclusion Criteria:

  • Patients that are not diagnosed with or treated for gastroesophageal diseases
  • Age \< 18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Overall Survival

    We will be examining all treatments of benign or malignant pancreatic cancer by measuring the following outcome: overall survival

    Time frame: 2005 to 2019

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Study locations

1 site
  • Trinity Surgical Consultants, Methodist Richardson Medical Center
    Richardson, Texas 75082, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04637256
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Nov 19, 2020
Start date
Mar 6, 2019
Primary completion
Feb 27, 2021
Completion
Mar 1, 2021
Last update
Jun 10, 2026

Study contacts

Dhiresh Jeyarajah, M.D.
principal investigator · Methodist Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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