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Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life

This study is currently recruiting participants.
Verified July 2017 by James Luketich, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT00260559
First Posted: December 1, 2005
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
James Luketich, University of Pittsburgh
  Purpose
To assess short and long term outcomes after minimally invasive esophagectomy compared to open esophagectomy. To compare both standard outcome measures as well as patient derived outcome measures, in particular, quality of life (QOL). To look at the applicability of this QOL instrument to this patient group.

Condition Intervention
Esophagectomy Esophageal Cancer Procedure: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life

Resource links provided by NLM:


Further study details as provided by James Luketich, University of Pittsburgh:

Estimated Enrollment: 3500
Study Start Date: May 1999
Estimated Study Completion Date: December 2050
Estimated Primary Completion Date: December 2050 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Questionnaires
    Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.
Detailed Description:
Assess short and long term outcomes after minimally invasive esophagectomy(MIE) compared to open esophagectomy. Measure standard observer derived outcomes such as morbidity, mortality, tumor recurrence and also patient derived outcomes, in particular quality of life (QOL) using the MOS SF36 questionnaire. Evaluate whether the SF36 will accurately reflect pre and postoperative changes in clinical status in this patient group.Compare the results of this global QOL instrument (SF 36) to disease specific scales of dysphagia and reflux. Assess the impact of adjuvant or neoadjuvant therapy on QOL in this patient group and determine if any advantages of MIE can be demonstrated.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.
Criteria

Inclusion Criteria:

  • Patients scheduled for MIE (Minimally Invasive Esophagectomy)
  • Patients scheduled for open esophagectomy
  • Signed informed consent

Exclusion Criteria:

  • Patients who are unable to comprehend or complete the QOL instruments.
  • Patients less than 18 years of age.
  Contacts and Locations
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): NCT00260559


Contacts
Contact: Julie A Ward, BSN 412-647-8583 wardj@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center - Heart, Lung, and Esophageal Surgical Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Julie A. Ward, BSN    412-647-8583    wardj@upmc.edu   
Principal Investigator: James D. Luketich, MD         
Sub-Investigator: Neil A. Christie, MD         
Sub-Investigator: Arjun Pennathur, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: Manisha Shende, MD         
Sub-Investigator: Lawrence Crist, MD         
Sub-Investigator: Ryan Levy, MD         
Sub-Investigator: Omar Awais, DO         
Sub-Investigator: Katie Nason, MD         
Sub-Investigator: Kevin McGrath, MD         
Sub-Investigator: Angela Gallagher, CRNP         
Sub-Investigator: Jason Lamb, MD         
Sub-Investigator: Jonathan D'Cunha, MD         
Sub-Investigator: Rajeev Dhupar, MD         
Sub-Investigator: Inderpal Sarkaria, MD         
Sub-Investigator: Manuel Villa Sanchez, MD         
Sub-Investigator: Jadsada Athigakunagorn, MD         
Sub-Investigator: Nicholas Baker, MD         
UPMC - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie A. Ward, BSN    412-647-8583    wardj@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: James D Luketich, MD UPMC - Heart, Lung, and Esophageal Surgery Institute
  More Information

Responsible Party: James Luketich, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00260559     History of Changes
Other Study ID Numbers: 99-0522
First Submitted: November 28, 2005
First Posted: December 1, 2005
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James Luketich, University of Pittsburgh:
Esophagectomy
Esophageal Cancer
Quality of Life
Minimally Invasive Esophagectomy
Laparoscopic Transhiatal Esophagectomy
Open Esophagectomy
Karnofsky Score
Dysphagia score
Heartburn Scale
Nutrition Score

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases


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