Esophageal Cancer Clinical Trial
Official title:
Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer
NCT number | NCT01558648 |
Other study ID # | 12-003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 14, 2012 |
Est. completion date | August 4, 2021 |
Verified date | April 2021 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.
Status | Completed |
Enrollment | 257 |
Est. completion date | August 4, 2021 |
Est. primary completion date | August 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 or older - Diagnosis of esophageal cancer, stages I-IIIC, with no prior esophageal resection. Neoadjuvant therapy given prior to presentation at MSKCC will be accepted. - Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, thoracoabdominal, or McKeown procedure) of esophageal cancer either by open or minimally invasive methods - Chest and abdomen CT scan - Ability to speak read and write English. Exclusion Criteria: - Inability to give informed consent - Patients requiring a laryngectomy or colon interposition as part of their surgical resection. - Patients with scleroderma. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | predict EUS T3/T4/stricture disease | To evaluate whether a combination of a dysphagia score of 2-4 and a specific CT scan maximal tumor thickness. the patient's CT scan (either performed elsewhere or at MSK) will be reviewed by one radiologist, who will assess the maximal thickness of tumor involvement (>=cm). Patients will then undergo their planned a staging Endoscopic ultrasonography (EUS) by the gastroenterology service, at which time the EUS depth of invasion will be assigned. The dysphagia score and CT thickness will then be compared to the EUS depth (considered the 'gold standard') | 2 years | |
Other | predict EUS T3/T4/stricture or earlier EUS disease | the patient's CT scan (either performed elsewhere or at MSK) will be reviewed by one radiologist, who will assess the maximal thickness of tumor involvement (>=cm). Patients will then undergo their planned staging Endoscopic ultrasonography (EUS) by the gastroenterology service, at which time the EUS depth of invasion will be assigned. The dysphagia score and CT thickness will then be compared to the EUS depth (considered the 'gold standard') | 2 years | |
Primary | short-term pain | Pain intensity (average of the four pain severity items) measured by BPI at Post-op Days 1 and 3, after epidural removal, at first post-operative clinic visit, at 4 months | 4 months | |
Primary | short -term quality of life (QOL) | FACT-E score at the post-op visit and at the 4 months | 4 months | |
Secondary | long-term pain | Pain intensity assessed by BPI at 8 months, 12 months, 18 months, 24 months (average of the four pain severity items) Presence of symptoms with intensity =3, as assessed by the Symptom Assessment Scale at post-op visit, at 4 months visit (adjusted for pre-operative symptom intensity ) | 2 years | |
Secondary | long time quality of life (QOL) | FACT- E score at 8 months, 12 months, 18 months, 24 months. Presence of symptoms with intensity =3, assessed by the Symptom Assessment Scale at 8 months, 12 months, 18 months, 24 months | 2 years | |
Secondary | differences in surgical outcomes | operative time, estimated blood loss, length of hospital stay, ICU admission rates, ICU days, complication type, rates and severity as determined by the Common Terminology Criteria for Adverse Events (CTCAE) utilized by MSKCC, rate of anastomotic leak, rate of anastomotic stricture, 90-day (post-operative) hospital readmission rates, time to oral intake, and time to first ambulation. | 90 days | |
Secondary | Complications | operative time, estimated blood loss, length of hospital stay, ICU admission rates, ICU days, complication type, rates and severity as determined by the Common Terminology Criteria for Adverse Events (CTCAE) utilized by MSKCC, rate of anastomotic leak, rate of anastomotic stricture, 90-day (post-operative) hospital readmission rates, time to oral intake, and time to first ambulation. | 90 days |
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