Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esophagectomy.
- Who it may be relevant to
- Registry conditions: Esophageal Malignant Neoplasm Primary, Anastomotic Leak. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gastric Preconditioning by Percutaneous Angioembolization Before Esophagectomy in Patients With a High Risk of Anastomotic Leak
Overview
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.
Interventions
- Procedure Esophagectomy
Eligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.
Primary outcome measures
- Incidence of anastomotic leak [Time frame: 1 year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (All protocol activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre
Identifiers
NCT: NCT07449208 · 26-045