NCT07449208 Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak
| NCT ID | NCT07449208 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Esophageal Malignant Neoplasm Primary |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2029-02-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-02-25 with a primary completion date of 2029-02-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of this study is to look at how often anastomotic leaks happen in participants who are at high risk of these leaks and are eligible to receive gastric preconditioning by percutaneous angioembolization before an esophagectomy.
Eligibility Criteria
Inclusion Criteria: * Documentation of Disease * Patients must have pathologically confirmed esophageal malignancy requiring esophagectomy. * Patients must also have risk factors for anastomotic leak: * Previous foregut or bariatric surgery (gastric sleeve or gastric bypass), but excluding fundoplication-only surgery OR * Salvage esophagectomy OR * Planned cervical anastomosis OR * Two or more comorbidities: * Diabetes, obesity, coronary artery disease, vascular disease (including celiac stricture or atherosclerosis, significant aortic disease, or any previous diagnosis of peripheral arterial disease), steroid use, hypertension, current or former smoker, renal insufficiency, and heart failure. * Definition of Disease * Patients must have pathologically confirmed esophageal malignancy requiring esophagectomy and risk factors for anastomotic leak, as described above. * Patients must be candidate and have agreed to receive gastric preconditioning procedure * Prior Treatment o There are no requirements with regard to prior treatment. * Age ≥ 18 * ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)
Contact & Investigator
Daniela Molena, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07449208 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Malignant Neoplasm Primary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07449208 currently recruiting?
Yes, NCT07449208 is actively recruiting participants. Contact the research team at molenad@mskcc.org for enrollment information.
Where is the NCT07449208 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT07449208 clinical trial?
NCT07449208 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Daniela Molena, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 40 participants.