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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2021
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log
Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.
Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log
Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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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