Esophagectomy With or Without Prior Ischemic Gastric Preconditioning
Stopped early · Not applicable
Conditions studied: Esophageal Cancer
In brief
This multi-center, randomized prospective clinical trial involves esophageal cancer patients who are surgical candidates. Patients will be randomized either to the one stage or the two stage esophagectomy procedure. Surgical, oncology outcomes, quality of life and cost analysis from both types of procedure will be reviewed and compared.
Key facts
- Study ID
- NCT02457299
- Run by
- Endeavor Health
- People needed
- 1
- Starts
- 2015-05-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2019-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is willing and able to provide written informed consent
- Subject is a candidate for esophagectomy with or without gastric pre-conditioning procedure per thoracic surgeon
- Patient is at least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Cancer stage: T1-2-3 N0M0, Locally advanced, T2-3 N1M0 based on American Joint Committee on Cancer (AJCC) 7th Edition by the oncologist
- No definitive radiological evidence of distant metastases as evaluated by CT or PET/CT scan
- Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including follow-up visits.
You may not qualify if…
- Patients < 18 years old
- History of invasive cancer within the past 5 years, (exceptions: non melanoma skin cancer, in situ cancers)
- Prior upper abdominal surgeries performed open and/or laparoscopic; such as but not limited to Nissen fundoplication, gastrectomy, bariatric surgery, hiatus hernia repair.
- Subject is participating in another investigational trial
- Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding
- Subject is part of the site personnel directly involved with this study
- Subject is a family member of the investigational study staff
Where it is running
- NorthShore University HealthSystem — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
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