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

NCT ID: NCT00260559

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-05-31

Study Completion Date

2050-12-31

Brief Summary

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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

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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.

Conditions

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Esophagectomy Esophageal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaires

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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James Luketich

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James D Luketich, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC - Department of Cardiothoracic Surgery

Locations

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University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julie A Ward, BSN

Role: CONTACT

412-647-8583

Facility Contacts

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Julie A. Ward, BSN

Role: primary

412-647-8583

Julie A. Ward, BSN

Role: primary

412-647-8583

Other Identifiers

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STUDY20040382

Identifier Type: -

Identifier Source: org_study_id

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