Phase
Condition
Digestive System Neoplasms
Esophageal Cancer
Esophageal Disorders
Treatment
Eso-SPONGE®
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic)transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer andsubsequent eso-SPONGE application to prevent anastomotic leakage
Patients able to read and understand the Patient Information Sheet and sign, ifaccepted, the Informed Consent Form
Patients able, at the discretion of the investigator, to comply with therequirements of the study and without impediments to follow the instructions andassessments throughout the study.
Exclusion
Exclusion Criteria:
Patients undergoing transhiatal esophagectomy without reconstruction, open IvorLewis esophagectomy or other esophageal resections different to ttMILE.
Multi-organ resection during the esophagectomy.
Emergent-urgent esophagectomy.
Coloplasty or small bowel plasty.
Necrotic tissue/gangrene.
Blood clotting disorder.
Bleeding esophageal varices.
Sponge placement required directly on major vessels.
Patients with known sensitivities or allergies to its components
Participation in any other clinical trial and use of any drug or experimentaldevice, currently or in the 4 weeks prior to inclusion in the study.
Women who are pregnant, suspected of being pregnant or breastfeeding.
Study Design
Study Description
Connect with a study center
Hospital Clinic de Barcelona
Barcelona, Catalunya 08036
SpainActive - Recruiting
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