Gastric preconditioning before esophagectomy for patients at high risk of anastomotic leak
Gastric Preconditioning by Percutaneous Angioembolization Before Esophagectomy in Patients With a High Risk of Anastomotic Leak
This registry will see if gastric preconditioning by percutaneous angioembolization before esophagectomy changes how often anastomotic leaks happen in people with esophageal cancer who are at high risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07449208 on ClinicalTrials.gov |
What this trial studies
This observational registry enrolls patients with pathologically confirmed esophageal cancer who are considered high risk for anastomotic leak and who are candidates for gastric preconditioning via percutaneous angioembolization prior to esophagectomy. Clinical teams will document baseline risk factors (for example prior foregut/bariatric surgery, salvage esophagectomy, planned cervical anastomosis, or multiple comorbidities), the use of preconditioning, surgical details, and postoperative outcomes including leak incidence. Data are collected across three Memorial Sloan Kettering locations in New Jersey and analyzed descriptively to characterize leak rates and related complications. No experimental therapies beyond standard-of-care preconditioning and esophagectomy are mandated by the registry.
Who should consider this trial
Good fit: People with pathologically confirmed esophageal cancer scheduled for esophagectomy who are at high risk for anastomotic leak (for example prior foregut/bariatric surgery, salvage esophagectomy, planned cervical anastomosis, or two or more specified comorbidities) and who agree to gastric preconditioning are ideal candidates.
Not a fit: Patients with low baseline leak risk, those not eligible for or who decline preconditioning, or those with contraindications to angioembolization are unlikely to gain benefit from this approach.
Why it matters
Potential benefit: If successful, preconditioning could reduce anastomotic leaks after esophagectomy, leading to fewer complications and faster recovery.
How similar studies have performed: Related concepts of gastric or ischemic preconditioning have been explored with mixed results, and percutaneous angioembolization before esophagectomy remains relatively novel and not yet proven in large trials.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Daniela Molena, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Daniela Molena, MD
- Email: molenad@mskcc.org
- Phone: 212-639-3870
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.