Gastric Preconditioning by Percutaneous Angioembolization Before Esophagectomy in Patients With a High Risk of Anastomotic Leak
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 7
- Primary Endpoint
- Incidence of anastomotic leak
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Esophagectomy (Procedure)
Outcomes
Primary Outcomes
Incidence of anastomotic leak
Time Frame: 1 year
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.
Secondary Outcomes
No secondary outcomes reported