EsophagectomyNCT00260559
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
An observational study of Esophagectomy and Esophageal Cancer, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, Esophageal Cancer
- What is being tested?
- Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 3,500 participants
- Where
- 2 sitesUnited States
- Study dates
- May 1999to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.
Who may be able to join
- Patients scheduled for MIE (Minimally Invasive Esophagectomy)
- Patients scheduled for open esophagectomy
- Signed informed consent
Who cannot join
- Patients who are unable to comprehend or complete the QOL instruments.
- Patients less than 18 years of age.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15213
Julie A. Ward, BSN, 412-647-8583, wardj@upmc.edu
James D. Luketich, MD
- Recruiting
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Julie A. Ward, BSN, 412-647-8583, wardj@upmc.edu
About this study
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.
Read the 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.
- Conditions
- Esophagectomy, Esophageal Cancer
- Being tested
- Questionnaires
- Keywords
- Esophagectomy, Esophageal Cancer, Quality of Life, Minimally Invasive Esophagectomy, Laparoscopic Transhiatal Esophagectomy, Open Esophagectomy, Karnofsky Score, Dysphagia score, Heartburn Scale, Nutrition Score
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesProcedure or surgery
Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 36 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startMay 1999
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Luketich, University of Pittsburgh
- Investigators
- James D Luketich, MD, Principal investigator, UPMC - Department of Cardiothoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260559
- Sponsor's protocol ID
- STUDY20040382
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2005
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
- ClinicalTrials.gov ID
- NCT00260559
- Acronym / sponsor ID
- STUDY20040382
- Conditions
- Esophagectomy, Esophageal Cancer
- Keywords
- Esophagectomy, Esophageal Cancer, Quality of Life, Minimally Invasive Esophagectomy, Laparoscopic Transhiatal Esophagectomy, Open Esophagectomy, Karnofsky Score, Dysphagia score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 1999
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.
Key inclusion criteria (3 listed)
- Patients scheduled for MIE (Minimally Invasive Esophagectomy)
- Patients scheduled for open esophagectomy
- Signed informed consent
Key exclusion criteria (2 listed)
- Patients who are unable to comprehend or complete the QOL instruments.
- Patients less than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively. | Procedure or surgery | – |
Primary outcome
Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative
Time frame: 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.
Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative
Time frame: 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 12 month postoperative
Time frame: 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
Time frame: 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 24 month
Time frame: 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 30 month
Time frame: 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 36 month
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Esophagectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
RecruitingPhase 3
Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
Esophageal Cancer
RecruitingPhase 2
OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
Anastomotic Leak Esophagus
Active, not recruitingObservational study
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Esophageal Cancer, Esophagus Cancer
RecruitingObservational study
Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery
Oesophageal Cancer, Oesophageal Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James D Luketich, MD principal investigator
UPMC - Department of Cardiothoracic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy and Esophageal Cancer, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie A Ward, BSN (412-647-8583, wardj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative (time frame: Baseline and 4 month postoperative). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.