Recruiting

Gastric Preconditioning

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07449208

Conditions

Esophageal Malignant Neoplasm Primary

Anastomotic Leak

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Esophagectomy

Study Details

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.

Conditions

Esophageal Malignant Neoplasm Primary

Anastomotic Leak

Study ID

NCT07449208

Start date

Feb 25, 2026

Status verified date

Feb, 2026

Completion date

Feb 25, 2029

Anticipated

Primary completion date

Feb 25, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak

Participants who are undergoing preoperative gastric preconditioning by percutaneous angioembolization before esophagectomy for esophageal malignancy and who have a high risk of anastomotic leak

Interventions

Esophagectomy

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

Primary outcome measure

  • Incidence of anastomotic leak [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Daniela Molena, MD

212-639-3870molenad@mskcc.org

Ernesto Santos Martin, MD

212-639-7327santosme@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Daniela Molena, MD

212-639-3870

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Daniela Molena, MD

212-639-3870

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Daniela Molena, MD

212-639-3870

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Daniela Molena, MD

212-639-3870

Memorial Sloan Kettering Westchester (All protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Daniela Molena, MD

212-639-3870

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Daniela Molena, MD

212-639-3870

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Daniela Molena, MD

212-639-3870

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

Keywords

  • esophageal malignancy
  • esophagectomy
  • anastomotic leak
  • Memorial Sloan Kettering Cancer Center
  • 26-045

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-03-04.