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RecruitingObservational

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

NCT ID: NCT00260559Sponsor: University of PittsburghLast updated: 2026-04-14

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.

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.

Arms & interventions

  • ProcedureQuestionnaires

    Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.

Outcome measures

Primary

  • Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative

    The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

    Time frame: Baseline and 4 month postoperative

  • Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative

    The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

    Time frame: Baseline and 6 month postoperative

  • Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative

    The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

    Time frame: Baseline and 12 month postoperative

  • Change from baseline in SF36 Quality of Life Questionnaire at 18 month

    The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

    Time frame: Baseline and 18 month postoperative

  • Change from baseline in SF36 Quality of Life Questionnaire at 24 month

    The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

    Time frame: Baseline and 24 month postoperative

  • Change from baseline in SF36 Quality of Life Questionnaire at 30 month

    The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

    Time frame: Baseline and 30 month postoperative

  • Change from baseline in SF36 Quality of Life Questionnaire at 36 month

    The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

    Time frame: Baseline and 36 month postoperative

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (2)

University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, 15213

Recruiting
Julie A. Ward, BSN · Contact
412-647-8583wardj@upmc.edu
James D. Luketich, MD · Principal Investigator
Neil A. Christie, MD · Sub Investigator
Arjun Pennathur, MD · Sub Investigator
Matthew Schuchert, MD · Sub Investigator
Ryan Levy, MD · Sub Investigator
Omar Awais, DO · Sub Investigator
Kevin McGrath, MD · Sub Investigator
Tadeusz Witek, MD · Sub Investigator
Evan Alicuben, MD · Sub Investigator
Christian Otero, MD · Sub Investigator
Renee Levesque, MD · Sub Investigator
James Ackerman, MD · Sub Investigator
Thomas Melvin, MD · Sub Investigator
Navid Ajabshir, MD · Sub Investigator

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting
Julie A. Ward, BSN · Contact
412-647-8583wardj@upmc.edu
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life | Cancerify