Using vacuum therapy to prevent leaks after esophageal cancer surgery

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

This study is testing if a special vacuum device can help prevent leaks after surgery for esophageal cancer in patients undergoing minimally invasive procedures.

Quick facts

• Study type: Observational
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aesculap AG (industry)
• Locations: 1 site (Barcelona, Catalonia)
• Trial ID: NCT06097078 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of preemptive endoluminal vacuum therapy (pEVT) in preventing anastomotic leakage following esophagectomy for esophageal cancer. Patients scheduled for minimally invasive esophagectomy will have the Eso-SPONGE® device placed endoscopically immediately after surgery to maintain negative pressure and promote healing. The study will involve multiple visits to assess the anastomosis for leakage, ischemia, and stenosis over a period of 90 days. Data on patient demographics and medical history will also be collected to support the findings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for total minimally invasive transthoracic Ivor Lewis esophagectomy due to esophageal cancer.

Not a fit: Patients undergoing different types of esophagectomy or those with certain medical conditions, such as blood clotting disorders or necrotic tissue, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of anastomotic leakage, improving recovery and outcomes for patients undergoing esophagectomy.

How similar studies have performed: While this approach is exploratory, similar studies using vacuum therapy in surgical settings have shown promising results, suggesting potential for success.

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.

Where this trial is running

Barcelona, Catalonia

• Hospital Clinic de Barcelona — Barcelona, Catalonia, Spain (RECRUITING)

Study contacts

• Principal investigator: Dulce Momblán García, Dr. — Hospital Clinic of Barcelona
• Study coordinator: Jaume Garcia López, Dr.

Conditions: Esophageal Cancer, Esophagus Cancer, Anastomotic Leak, endoluminal vacuum therapy, anastomotic leakage, esophagectomy, esophageal cancer, abdominal and cardiac surgery