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

Last updated: October 23, 2024
Sponsor: Aesculap AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Esophageal Cancer

Esophageal Disorders

Treatment

Eso-SPONGE®

Clinical Study ID

NCT06097078
AAG-O-H-2209
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic)transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer andsubsequent eso-SPONGE application to prevent anastomotic leakage

  • Patients able to read and understand the Patient Information Sheet and sign, ifaccepted, the Informed Consent Form

  • Patients able, at the discretion of the investigator, to comply with therequirements of the study and without impediments to follow the instructions andassessments throughout the study.

Exclusion

Exclusion Criteria:

  • Patients undergoing transhiatal esophagectomy without reconstruction, open IvorLewis 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 experimentaldevice, currently or in the 4 weeks prior to inclusion in the study.

  • Women who are pregnant, suspected of being pregnant or breastfeeding.

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Eso-SPONGE®
Phase:
Study Start date:
October 07, 2024
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Hospital Clinic de Barcelona

    Barcelona, Catalunya 08036
    Spain

    Active - Recruiting

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