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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Esophageal Cancer, Esophagus Cancer, Anastomotic Leak

Intervention / Treatment
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* Device: Eso-SPONGE®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eso-SPONGE®<br>endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer | Device: Eso-SPONGE®<br>* minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)<br>* Other names: endoluminal vacuum therapy (EVT) device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with anastomotic leakage | 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. | throughout the duration of the study (until last follow-up at postoperative day 90) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication Index | The Comprehensive Complication Index (CCI®) calculates the overall morbidity of a patient after any surgical intervention based on the complication grading by the Clavien-Dindo Classification (CDC). The Comprehensive Complication Index (CCI®) reflects the gravity of this overall complication burden on the patient on a scale from 0 (no complication) to 100 (death). | Postoperative day 30 and day 90 | 
| Description of Adverse Events | All the Adverse Events reported during the study will be described together with their characteristics, noting those related with the investigational device application. | throughout the duration of the study (until last follow-up at postoperative day 90) | 
| Rate of postoperative ischemia | The different grades of postoperative ischemia at Visit 1, Visit 2 and Visit 3 | Postoperative day 30 and day 90 | 
| Rate of postoperative mortality | The percentage of patients who died along the study will be described in terms of absolute and relative frequencies, as well as causes for death and time until death regarding investigational device application. | Postoperative day 30 and day 90 | 
| Rate of postoperative stenosis | The percentage of postoperative stenosis at Visit 1, Visit 2 and Visit 3, as well as along the study | throughout the duration of the study (until last follow-up at postoperative day 90) | 
| Length of hospitalization | time elapsed until reaching the fit for discharge criteria regarding investigational device application | until discharge (approximately 10 days postoperatively) | 
| Re-admissions to hospital | The percentage of patients re-admitted along the study will be described; as well as the time elapsed until re-admission regarding investigational device application | throughout the duration of the study (until last follow-up at postoperative day 90) | 
| Surgical reoperations | The percentage of patients with surgical reoperations along the study will be described; as well as the time elapsed until surgical reoperation regarding investigational device application | throughout the duration of the study (until last follow-up at postoperative day 90) | 
| Anastomotic leakage free survival | Event free survival at 30 days and at 90 days will be analyzed using Kaplan-Meier method, considering the anastomotic leakage reported during the study. Patients with no anastomotic leakage during the analyzed period will be censored at last follow-up date | throughout the duration of the study (until last follow-up at postoperative day 90) | 
| Rate of intraluminal hemorrhage | The percentage of patients with intraluminal hemorrhage along the study will be described in terms of absolute and relative frequencies; as well as the time elapsed until hemorrhage regarding investigational device application. Additionally, to see the distribution of the time until intraluminal hemorrhage Kaplan-Meier method will be performed at 90 days (patients with no intraluminal hemorrhage during the study will be censored at last follow-up date). | throughout the duration of the study (until last follow-up at postoperative day 90) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoluminal vacuum therapy, anastomotic leakage, esophagectomy, esophageal cancer, abdominal and cardiac surgery