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
1 other identifier
observational
40
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2026
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2026
CompletedFirst Submitted
Initial submission to the registry
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 25, 2029
March 4, 2026
February 1, 2026
3 years
February 27, 2026
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Eligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.
Eligibility Criteria
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.
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Molena, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 4, 2026
Study Start
February 25, 2026
Primary Completion (Estimated)
February 25, 2029
Study Completion (Estimated)
February 25, 2029
Last Updated
March 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.