NCT06097078Active, not recruiting
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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 cancer. The main objective is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 44 (estimated)
- First submitted
- 16 Oct 2023
- Start date
- 7 Oct 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Aesculap AG
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06097078
What you commit to
- Study type: Observational
- Planned participants: 44
- From 7 Oct 2024 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Multi-organ resection during the esophagectomy.
- 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.
Other illness
- Blood clotting disorder.
- Bleeding esophageal varices.
- Patients with known sensitivities or allergies to its components
Other
- Patients undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis esophagectomy or other esophageal resections different to ttMILE.
- Emergent-urgent esophagectomy.
- Coloplasty or small bowel plasty.
- Necrotic tissue/gangrene.
- Sponge placement required directly on major vessels.
- Women who are pregnant, suspected of being pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.