Recruiting

Minimally Invasive Esophagectomy

Sponsor:

University of Pittsburgh

Code:

NCT00260559

Conditions

Esophagectomy

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Study Details

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.

Conditions

Esophagectomy

Esophageal Cancer

Study ID

NCT00260559

Start date

May, 1999

Status verified date

Mar, 2026

Completion date

Dec, 2050

Anticipated

Primary completion date

Dec, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

3500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Questionnaires

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

Primary outcome measure

  • Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative [ Time Frame: Baseline and 4 month postoperative ]
  • Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative [ Time Frame: Baseline and 6 month postoperative ]
  • Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative [ Time Frame: Baseline and 12 month postoperative ]
  • Change from baseline in SF36 Quality of Life Questionnaire at 18 month [ Time Frame: Baseline and 18 month postoperative ]
  • Change from baseline in SF36 Quality of Life Questionnaire at 24 month [ Time Frame: Baseline and 24 month postoperative ]
  • Change from baseline in SF36 Quality of Life Questionnaire at 30 month [ Time Frame: Baseline and 30 month postoperative ]
  • Change from baseline in SF36 Quality of Life Questionnaire at 36 month [ Time Frame: Baseline and 36 month postoperative ]

Central Contacts and Locations

Central contacts

Julie A Ward, BSN

412-647-8583wardj@upmc.edu

Locations

University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Julie A. Ward, BSN

412-647-8583wardj@upmc.edu

Principal Investigator:

James D. Luketich, MD

UPMC - Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Julie A. Ward, BSN

412-647-8583wardj@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 14, 2026

Last verified

Mar, 2026

Keywords

  • Esophagectomy
  • Esophageal Cancer
  • Quality of Life
  • Minimally Invasive Esophagectomy
  • Laparoscopic Transhiatal Esophagectomy
  • Open Esophagectomy
  • Karnofsky Score
  • Dysphagia score
  • Heartburn Scale
  • Nutrition Score

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-14.