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OpenTrials
Completed

NCT Number: NCT01558648

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

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log

Behavioral

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.

Primary outcomes

  1. short-term pain

    Time frame: 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

  2. short -term quality of life (QOL)

    Time frame: 4 months

    FACT-E score at the post-op visit and at the 4 months

Secondary outcomes

  1. long-term pain

    Time frame: 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 )

  2. long time quality of life (QOL)

    Time frame: 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

  3. differences in surgical outcomes

    Time frame: 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.

  4. Complications

    Time frame: 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.

Other outcomes

  1. predict EUS T3/T4/stricture disease

    Time frame: 2 years

    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. predict EUS T3/T4/stricture or earlier EUS disease

    Time frame: 2 years

    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')

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2012
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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