Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer

Launched by AESCULAP AG · Oct 20, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called Endoluminal Vacuum Therapy (pEVT) to see if it can help prevent a common problem called anastomotic leakage after surgery for esophageal cancer. After removing the esophagus, doctors usually join the remaining parts together, and sometimes this area can leak, which can lead to serious complications. The researchers want to find out if using pEVT before any leaks happen can help keep the surgical connection safe and reduce the chances of leakage.

To participate in this study, you need to be at least 18 years old and scheduled to undergo a specific type of surgery called a minimally invasive esophagectomy due to esophageal cancer. You'll also need to be able to understand the information provided and agree to participate by signing a consent form. If you join the study, you'll receive the pEVT therapy and be monitored throughout the process. It's important to note that certain conditions, like having other serious health issues or undergoing different types of surgery, might make you ineligible for the trial. Overall, the goal is to improve patient outcomes following esophageal cancer surgery.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.