Gastric preconditioning before esophagectomy for patients at high risk of anastomotic leak

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.