Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
NCT ID: NCT06097078
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
44 participants
OBSERVATIONAL
2024-10-07
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Eso-SPONGE®
endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer
Eso-SPONGE®
minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)
Interventions
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Eso-SPONGE®
minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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B.Braun Surgical SA
INDUSTRY
Aesculap AG
INDUSTRY
Responsible Party
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Principal Investigators
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Dulce Momblán García, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Dulce Momblán García, Dr.
Role: primary
Other Identifiers
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AAG-O-H-2209
Identifier Type: -
Identifier Source: org_study_id
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