Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documentation of Disease
Patients must have pathologically confirmed esophageal malignancy requiring esophagectomy.
Previous foregut or bariatric surgery (gastric sleeve or gastric bypass), but excluding fundoplication-only surgery OR
Salvage esophagectomy OR
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Esophagectomy
Procedure/SurgeryEligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Participants Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak1 intervention
Trial outcomes
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov