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

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. Identifier: NCT00260559
Recruitment Status : Recruiting
First Posted : December 1, 2005
Last Update Posted : August 21, 2018
Information provided by (Responsible Party):
James Luketich, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment
Esophagectomy Esophageal Cancer Procedure: Questionnaires

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.

Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Study Start Date : May 1999
Estimated Primary Completion Date : December 2050
Estimated Study Completion Date : December 2050

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Questionnaires
    Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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 identifier (NCT number): 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         
Sub-Investigator: Nicholas Baker, 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

Responsible Party: James Luketich, MD, University of Pittsburgh Identifier: NCT00260559     History of Changes
Other Study ID Numbers: 99-0522
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James Luketich, 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