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

Recruiting

• Conditions: Esophageal Cancer; Esophagectomy

• Registration Number: NCT00260559
• Lead Sponsor: University of Pittsburgh

Brief 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.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-16
• Primary Completion: 2050-12
• Study Completion: 2050-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in SF36 Quality of Life Questionnaire at 24 month	Baseline and 24 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.
Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative	Baseline and 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.
Change from baseline in SF36 Quality of Life Questionnaire at 30 month	Baseline and 30 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.
Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative	Baseline and 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.
Change from baseline in SF36 Quality of Life Questionnaire at 18 month	Baseline and 18 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.
Change from baseline in SF36 Quality of Life Questionnaire at 36 month	Baseline and 36 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.
Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative	Baseline and 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.

Trial Locations

Locations (2)

University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC - Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States