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

This study is currently recruiting participants.

Verified by University of Pittsburgh, October 2008

First Received: November 28, 2005 Last Updated: October 13, 2008 History of Changes

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00260559

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:	Case-Only, Prospective
Official Title:	Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Heartburn

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	May 1999

Intervention Details:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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: Miguel Alvelo-Rivera, MD
Sub-Investigator: Sebastien Gilbert, MD
Sub-Investigator: Neil A. Christie, MD
Sub-Investigator: Rodney J. Landreneau, MD
Sub-Investigator: Arjun Pennathur, MD
Sub-Investigator: Ghulam Abbas
Sub-Investigator: Matthew Schuchert, MD
Sub-Investigator: Brian Pettiford, MD
Sub-Investigator: Kevin McGrath, MD
Sub-Investigator: Stephanie Land, PhD.
Sub-Investigator: Patricia Churilla, CRNP
Sub-Investigator: Manisha Shende, MD
Sub-Investigator: Angela Gallagher, CRNP
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

No publications provided

Responsible Party:	University of Pittsburgh ( James Luketich, MD )
Study ID Numbers:	99-0522
Study First Received:	November 28, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00260559 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

Study placed in the following topic categories:

Pyrosis
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Quality of Life
Esophageal Cancer
Deglutition Disorders

Digestive System Diseases
Esophageal Disorder
Head and Neck Neoplasms
Heartburn
Gastrointestinal Neoplasms
Esophageal Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on July 06, 2009