Comparing outcomes of minimally invasive and open esophagectomy for esophageal cancer
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
This study is trying to see if patients with esophageal cancer do better in terms of recovery and quality of life after having a minimally invasive surgery compared to traditional open surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT00260559 on ClinicalTrials.gov |
What this trial studies
This study assesses the short and long-term outcomes of patients undergoing minimally invasive esophagectomy (MIE) compared to those undergoing open esophagectomy for esophageal cancer. It focuses on both standard clinical outcomes, such as morbidity and mortality, and patient-derived outcomes, particularly quality of life (QOL) as measured by the MOS SF36 questionnaire. The study aims to evaluate the effectiveness of the SF36 in reflecting changes in clinical status and to compare these results with disease-specific scales related to dysphagia and reflux. Additionally, it examines the impact of adjuvant or neoadjuvant therapy on QOL in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for either minimally invasive or open esophagectomy for esophageal cancer who can provide informed consent.
Not a fit: Patients who are unable to comprehend or complete the quality of life instruments or those under 18 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the benefits of minimally invasive techniques on quality of life for patients undergoing esophagectomy.
How similar studies have performed: Other studies have shown promising results with minimally invasive approaches in surgical outcomes, suggesting potential benefits in quality of life, making this a relevant area of investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: James D Luketich, MD — UPMC - Department of Cardiothoracic Surgery
- Study coordinator: Julie A Ward, BSN
- Email: wardj@upmc.edu
- Phone: 412-647-8583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.