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

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

NCT ID: NCT06097078

Condition: Esophageal Cancer
Esophagus Cancer
Anastomotic Leak

Conditions: Official terms:
Esophageal Neoplasms
Anastomotic Leak

Conditions: Keywords:
endoluminal vacuum therapy
anastomotic leakage
esophagectomy
esophageal cancer
abdominal and cardiac surgery

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Eso-SPONGE®
Description: minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)
Arm group label: Eso-SPONGE®

Other name: endoluminal vacuum therapy (EVT) device

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 cancer. The main objective is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.

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. The study comprises a maximum of 5 visits per protocol. At visit 0, informed consent will be obtained, and the patient will be checked for compliance with all inclusion criteria and no exclusion criteria in the study. Demographic characteristics, medical history and oncological parameters will be collected. At visit 1 ttMILE will be carry out and immediately (0-24h) after completion of the anastomosis, in patients who meet selection criteria, the Eso-SPONGE® will be placed endoscopically via an overtube, as usual clinical practice of the centre. The tube will be routed transnasally and then connected to a vacuum pump, generating a continuous negative pressure of 75 mmHg. The Eso-SPONGE system will be checked 6-hourly for leakage and dislocation. The sponge will be removed after 4-6 days (V2). After removal, the anastomosis and the gastric tube will be assessed endoscopically to exclude leakage and evaluate ischemia and stenosis, and the pylorus will be evaluated for spasm. The next visits (V3 and V4) will be carried out at 30 and 90 days after the intervention has been placed. Leakage, ischemia and stenosis will be clinically evaluated at each visit and a new endoscopy will be performed in patient who show symptoms.

Criteria for eligibility:

Study pop:
Patients undergoing a 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 (AL)

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Status: Recruiting

Contact:
Last name: Dulce Momblán García, Dr.

Start date: October 7, 2024

Completion date: October 2025

Lead sponsor:
Agency: Aesculap AG
Agency class: Industry

Collaborator:
Agency: B.Braun Surgical SA
Agency class: Industry

Source: Aesculap AG

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06097078