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Clinical Trials/NCT01558648
NCT01558648
Completed
Not Applicable

Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

Memorial Sloan Kettering Cancer Center1 site in 1 country257 target enrollmentMarch 14, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
257
Locations
1
Primary Endpoint
short-term pain
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.

Registry
clinicaltrials.gov
Start Date
March 14, 2012
End Date
August 4, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • Diagnosis of esophageal cancer, stages I-IIIC, with no prior esophageal resection. Neoadjuvant therapy given prior to presentation at MSKCC will be accepted.
  • Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, thoracoabdominal, or McKeown procedure) of esophageal cancer either by open or minimally invasive methods
  • Chest and abdomen CT scan
  • Ability to speak read and write English.

Exclusion Criteria

  • Inability to give informed consent
  • Patients requiring a laryngectomy or colon interposition as part of their surgical resection.
  • Patients with scleroderma.

Outcomes

Primary Outcomes

short-term pain

Time Frame: 4 months

Pain intensity (average of the four pain severity items) measured by BPI at Post-op Days 1 and 3, after epidural removal, at first post-operative clinic visit, at 4 months

short -term quality of life (QOL)

Time Frame: 4 months

FACT-E score at the post-op visit and at the 4 months

Secondary Outcomes

  • Complications(90 days)
  • long time quality of life (QOL)(2 years)
  • long-term pain(2 years)
  • differences in surgical outcomes(90 days)

Study Sites (1)

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