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| Sponsor: | 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 |
| Estimated Enrollment: | 600 |
| Study Start Date: | May 1999 |
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 |
Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Julie A Ward, BSN | 412-647-8583 | wardj@upmc.edu |
| 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 | |
| Principal Investigator: | James D Luketich, MD | UPMC - Heart, Lung, and Esophageal Surgery Institute |
More Information
| 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 |
|
Esophagectomy Esophageal Cancer Quality of Life Minimally Invasive Esophagectomy Laparoscopic Transhiatal Esophagectomy |
Open Esophagectomy Karnofsky Score Dysphagia score Heartburn Scale Nutrition Score |
|
Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |
