Clinical trial NCT06097078: Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Esophagus Cancer
Anastomotic Leak
Keywords: endoluminal vacuum therapy
anastomotic leakage
esophagectomy
esophageal cancer
abdominal and cardiac surgery
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-10-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief 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.

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.

Primary outcomes:
measure: Rate of patients with anastomotic leakage
timeFrame: throughout the duration of the study (until last follow-up at postoperative day 90)
Secondary outcomes:
measure: Comprehensive Complication Index
timeFrame: Postoperative day 30 and day 90
measure: Description of Adverse Events
timeFrame: throughout the duration of the study (until last follow-up at postoperative day 90)
measure: Rate of postoperative ischemia
timeFrame: Postoperative day 30 and day 90
measure: Rate of postoperative mortality
timeFrame: Postoperative day 30 and day 90
measure: Rate of postoperative stenosis
timeFrame: throughout the duration of the study (until last follow-up at postoperative day 90)
measure: Length of hospitalization
timeFrame: until discharge (approximately 10 days postoperatively)
measure: Re-admissions to hospital
timeFrame: throughout the duration of the study (until last follow-up at postoperative day 90)
measure: Surgical reoperations
timeFrame: throughout the duration of the study (until last follow-up at postoperative day 90)
measure: Anastomotic leakage free survival
timeFrame: throughout the duration of the study (until last follow-up at postoperative day 90)
measure: Rate of intraluminal hemorrhage
timeFrame: throughout the duration of the study (until last follow-up at postoperative day 90)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Catalunya
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Dulce Momblán García, Dr.
role: PRINCIPAL_INVESTIGATOR
References: