Registry Study for Esophagectomy and Anastomotic Leak Risk

This study is for people who need an esophagectomy (surgery to remove part of your esophagus, the tube that carries food to your stomach) and are at high risk for an anastomotic leak (when the connection made during surgery doesn't heal properly). The study will observe participants who receive a procedure called gastric preconditioning by percutaneous angioembolization before their esophagectomy. The main goal is to see how often anastomotic leaks happen in these high-risk patients within one year after surgery. You may be able to join if you have esophageal cancer requiring this surgery and have certain risk factors, such as previous stomach or weight-loss surgery. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without assigning specific treatments. It plans to include 40 participants.
What's involved
Eligible participants will undergo an esophagectomy after receiving preoperative gastric preconditioning by percutaneous angioembolization.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for the incidence of anastomotic leak, measured at 1 year.

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NCT07449208

Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~40 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Esophagectomy

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of anastomotic leak
Measured over 1 year
Esophageal Malignant Neoplasm Primary
Anastomotic Leak

NCT07449208

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Rockville Centre, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (All protocol activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Daniela Molena, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

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
Age ≥ 18
ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)
  • Incidence of anastomotic leak1 year

    Determine the incidence of anastomotic leak among participants with a high risk of esophageal leak who undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.