Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

Completed

• Conditions: Esophageal Cancer
• Interventions: Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log

• Registration Number: NCT01558648
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-14
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Status Verified: 2021-04
• Primary Completion: 2021-08-04
• Study Completion: 2021-08-04
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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.

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Exclusion Criteria

• Inability to give informed consent
• Patients requiring a laryngectomy or colon interposition as part of their surgical resection.
• Patients with scleroderma.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pts having Minimally Invasive esophagectomy	Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log	This is a prospective non-randomized study comprising two surgical cohorts of esophageal cancer patients. Patients will be assigned to each of the two intervention groups, MIE versus OE, based on a combination of patient referral patterns, patient preference, and surgeon preference/expertise.
Pts having open esophagectomy	Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log	This is a prospective non-randomized study comprising two surgical cohorts of esophageal cancer patients. Patients will be assigned to each of the two intervention groups, MIE versus OE, based on a combination of patient referral patterns, patient preference, and surgeon preference/expertise.

Primary Outcome Measures

Name	Time	Method
short-term pain	4 months	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
short -term quality of life (QOL)	4 months	FACT-E score at the post-op visit and at the 4 months

Secondary Outcome Measures

Name	Time	Method
Complications	90 days	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.
long time quality of life (QOL)	2 years	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
long-term pain	2 years	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 )
differences in surgical outcomes	90 days	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States