Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak (NCT07449208) | Clinical Trial Compass
RecruitingNot Applicable
Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak
United States40 participantsStarted 2026-02-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)