Comparing two types of anesthesia for esophageal cancer surgery
Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
This study is testing whether a new type of anesthesia can help people with esophageal cancer have better recovery and fewer chances of their cancer coming back after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1614 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04513808 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of propofol-based total intravenous anesthesia versus sevoflurane-based balanced general anesthesia in patients undergoing potentially curative surgery for esophageal cancer. The primary focus is on measuring recurrence-free survival rates post-surgery, with secondary goals including the speed of discharge from the ICU and hospital, as well as the quality of recovery assessed by the QoR-15 scale on postoperative day 2. Patients will be randomly assigned to one of the two anesthesia methods to evaluate these outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with primary esophageal cancer at stages 1-3 scheduled for curative surgery.
Not a fit: Patients with previous esophageal cancer surgeries, severe systemic diseases, or contraindications to the anesthesia types will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and recovery experiences for patients undergoing surgery for esophageal cancer.
How similar studies have performed: Other studies have shown promising results with similar anesthesia approaches, suggesting potential benefits in surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3). * Scheduled for potentially curative esophageal cancer surgery. * Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia. Exclusion Criteria: * Previous surgery for esophageal cancer (except diagnostic biopsies) Age \<18 or \>85 years old. * ASA Physical Status ≥4. * Any contraindication to propofol or sevoflurane. * Other cancer not believed by the attending surgeon to be in long-term remission. * Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.
Where this trial is running
Shanghai
- Shanhai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Yuwei Oui, MD — Shahai Hospital
- Study coordinator: Daniel I Sessler, MD
- Email: DS@CCF.org
- Phone: 216-870-2620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.