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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagectomy | Procedure | Eligible participants will undergo esophagectomy after preoperative gastric preconditioning by percutaneous angioembolization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Documentation of Disease
Definition of Disease
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)
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Molena, MD | Contact | 212-639-3870 | molenad@mskcc.org | |
| Ernesto Santos Martin, MD | Contact | 212-639-7327 | santosme@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Molena, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (All protocol activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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