NCT00260559

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
299mo left

Started May 1999

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
May 1999Dec 2050

Study Start

First participant enrolled

May 1, 1999

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
45 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2050

Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

51.6 years

First QC Date

November 28, 2005

Last Update Submit

April 9, 2026

Conditions

EsophagectomyEsophageal Cancer

Keywords

EsophagectomyEsophageal CancerQuality of LifeMinimally Invasive EsophagectomyLaparoscopic Transhiatal EsophagectomyOpen EsophagectomyKarnofsky ScoreDysphagia scoreHeartburn ScaleNutrition Score

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline and 36 month postoperative

Interventions

QuestionnairesPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.

You may qualify if:

  • Patients scheduled for MIE (Minimally Invasive Esophagectomy)
  • Patients scheduled for open esophagectomy
  • Signed informed consent

You may not qualify if:

  • Patients who are unable to comprehend or complete the QOL instruments.
  • Patients less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • James D Luketich, MD

    UPMC - Department of Cardiothoracic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie A Ward, BSN

CONTACT

412-647-8583wardj@upmc.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 28, 2005

First Posted

December 1, 2005

Study Start

May 1, 1999

Primary Completion (Estimated)

December 1, 2050

Study Completion (Estimated)

December 1, 2050

Last Updated

April 14, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)