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

NCT06097078 | Recruiting

• 1 other identifier: AAG-O-H-2209
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Esophagus Cancer; Anastomotic Leak

Keywords

endoluminal vacuum therapy; anastomotic leakage; esophagectomy; esophageal cancer; abdominal and cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Comprehensive Complication Index

  Postoperative day 30 and day 90

• Description of Adverse Events

  throughout the duration of the study (until last follow-up at postoperative day 90)

• Rate of postoperative ischemia

  Postoperative day 30 and day 90

• Rate of postoperative mortality

  Postoperative day 30 and day 90

• Rate of postoperative stenosis

  throughout the duration of the study (until last follow-up at postoperative day 90)

Study Arms (1)

Eso-SPONGE®

endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer

Device: Eso-SPONGE®

Interventions

Eso-SPONGE® DEVICE

minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)

Also known as: endoluminal vacuum therapy (EVT) device

Eso-SPONGE®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dulce Momblán García, Dr.

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaume Garcia López, Dr.

CONTACT

+34935866200; info@bbraun.com

José Manuel M Molina, Dr.

CONTACT

+34 935 86 62; info@bbraun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 24, 2023
• Study Start: October 7, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)