Clinical trial · Observational
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophagus Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eso-SPONGE® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Eso-SPONGE®
- description
- endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer
- interventionNames
- Device: Eso-SPONGE®
Primary outcomes (1)
- measure
- Rate of patients with anastomotic leakage
- timeFrame
- throughout the duration of the study (until last follow-up at postoperative day 90)
- description
- Anastomotic leakage (AL) is a severe complication following gastric and esophageal surgery. Anastomotic leakage occurs in 5-30% of patients after esophagectomy and may be further complicated by mediastinitis, sepsis, multiple organ failure, or death. The primary objective of the study is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
Secondary outcomes (10)
- measure
- Comprehensive Complication Index
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available