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OpenTrials
Completed

NCT Number: NCT04637256

Evaluation of Outcomes From Treatment of Benign or Malignant Gastroesophageal Diseases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Trinity Surgical Consultants, Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

About this study

  • 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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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