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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: November 28, 2005
Last updated: December 1, 2015
Last verified: December 2015
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
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 University of Pittsburgh:

Estimated Enrollment: 1200
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.

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00260559

Contact: Julie A Ward, BSN 412-647-8583

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   
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         
UPMC - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie A. Ward, BSN    412-647-8583   
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: James D Luketich, MD UPMC - Heart, Lung, and Esophageal Surgery Institute
  More Information

Responsible Party: University of Pittsburgh Identifier: NCT00260559     History of Changes
Other Study ID Numbers: 99-0522
Study First Received: November 28, 2005
Last Updated: December 1, 2015

Keywords provided by University of Pittsburgh:
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
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on May 23, 2017