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Recruiting

NCT Number: NCT07449208

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

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.

Recruiting

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Key information

Conditions

Esophageal Malignant Neoplasm Primary Anastomotic Leak Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Esophagectomy

Procedure

Eligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.

Primary outcomes

  1. Incidence of anastomotic leak

    Time frame: 1 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Molena, MD

CONTACT

[email protected]

212-639-3870

Ernesto Santos Martin, MD

CONTACT

[email protected]

212-639-7327

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Gastric Preconditioning by Percutaneous Angioembolization Before Esophagectomy in Patients With a High Risk of Anastomotic Leak

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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