Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 12:55 PM
Study NCT ID:
NCT00260559
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2005-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '1999-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2005-11-28', 'studyFirstSubmitQcDate': '2005-11-28', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative', 'timeFrame': 'Baseline and 4 month postoperative', 'description': '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.'}, {'measure': 'Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative', 'timeFrame': 'Baseline and 6 month postoperative', 'description': '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.'}, {'measure': 'Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative', 'timeFrame': 'Baseline and 12 month postoperative', 'description': '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.'}, {'measure': 'Change from baseline in SF36 Quality of Life Questionnaire at 18 month', 'timeFrame': 'Baseline and 18 month postoperative', 'description': '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.'}, {'measure': 'Change from baseline in SF36 Quality of Life Questionnaire at 24 month', 'timeFrame': 'Baseline and 24 month postoperative', 'description': '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.'}, {'measure': 'Change from baseline in SF36 Quality of Life Questionnaire at 30 month', 'timeFrame': 'Baseline and 30 month postoperative', 'description': '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.'}, {'measure': 'Change from baseline in SF36 Quality of Life Questionnaire at 36 month', 'timeFrame': 'Baseline and 36 month postoperative', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophagectomy', 'Esophageal Cancer', 'Quality of Life', 'Minimally Invasive Esophagectomy', 'Laparoscopic Transhiatal Esophagectomy', 'Open Esophagectomy', 'Karnofsky Score', 'Dysphagia score', 'Heartburn Scale', 'Nutrition Score'], 'conditions': ['Esophagectomy', 'Esophageal Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seeking surgical resection of their esophagus at the University of Pittsburgh Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for MIE (Minimally Invasive Esophagectomy)\n* Patients scheduled for open esophagectomy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients who are unable to comprehend or complete the QOL instruments.\n* Patients less than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT00260559', 'briefTitle': 'Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life', 'orgStudyIdInfo': {'id': 'STUDY20040382'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaires', 'type': 'PROCEDURE', 'description': 'Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie A. Ward, BSN', 'role': 'CONTACT', 'email': 'wardj@upmc.edu', 'phone': '412-647-8583'}, {'name': 'James D. Luketich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Neil A. Christie, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arjun Pennathur, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthew Schuchert, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ryan Levy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Omar Awais, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kevin McGrath, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Angela Gallagher, CRNP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tadeusz Witek, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Evan Alicuben, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christian Otero, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Renee Levesque, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'James Ackerman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Melvin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Navid Ajabshir, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie A. Ward, BSN', 'role': 'CONTACT', 'email': 'wardj@upmc.edu', 'phone': '412-647-8583'}], 'facility': 'UPMC - Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Julie A Ward, BSN', 'role': 'CONTACT', 'email': 'wardj@upmc.edu', 'phone': '412-647-8583'}], 'overallOfficials': [{'name': 'James D Luketich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPMC - Department of Cardiothoracic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'James Luketich', 'investigatorAffiliation': 'University of Pittsburgh'}}}}