Status:
RECRUITING
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Esophageal Cancer
Esophagus Cancer
Eligibility:
All Genders
18+ years
Brief Summary
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal ca...
Detailed Description
Prospective, multi-centre, exploratory and observational one-arm study to evaluate preemptive endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer. T...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE application to prevent anastomotic leakage
- Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form
- Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.
Exclusion
- Patients undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis 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 experimental device, currently or in the 4 weeks prior to inclusion in the study.
- Women who are pregnant, suspected of being pregnant or breastfeeding.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06097078
Start Date
October 7 2024
End Date
April 1 2026
Last Update
November 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036