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

Gastric Preconditioning by Percutaneous Angioembolization Before Esophagectomy in Patients With a 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.

Study Overview

• Status: Recruiting
• Conditions: Anastomotic Leak; Esophageal Malignant Neoplasm Primary
• Intervention / Treatment: Procedure: Esophagectomy

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Daniela Molena, MD; Phone Number: 212-639-3870; Email: molenad@mskcc.org
• Study Contact Backup: Name: Ernesto Santos Martin, MD; Phone Number: 212-639-7327; Email: santosme@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All protocol activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All protocol activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All protocol activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All protocol activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All protocol activities)
      • Contact: Daniela Molena, MD; Phone Number: 212-639-3870

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All study participants will be recruited from the Thoracic Surgery clinics at MSK. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or the research team by screening of patient medical records to identify suitable research study participants. The study will be discussed with each eligible patient. All potential risks and benefits associated with the study will be discussed with the patient. All patients will be monitored by the enrolling investigator. All patients who meet the above criteria will be eligible irrespective of sex, gender, ethnicity, or smoking status. Before enrollment, all potential risks and benefits associated with the study will be discussed with the patient. Patients who do not consent to study enrollment will still be eligible for percutaneous gastric preconditioning and all standard of care management of their cancer.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Esophagectomy; Eligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anastomotic leak	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.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Daniela Molena, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2026
• Primary Completion (Estimated): February 25, 2029
• Study Completion (Estimated): February 25, 2029

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anastomotic leak; Memorial Sloan Kettering Cancer Center; esophagectomy; esophageal malignancy; 26-045
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anastomotic Leak; Surgical Procedures, Operative; Digestive System Surgical Procedures; Esophagectomy
• Other Study ID Numbers: 26-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No