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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer; Anastomotic Leak; Esophagus Cancer
• Intervention / Treatment: Device: Eso-SPONGE®

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.

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Ricard Rosique; Email: info@bbraun.com
• Study Contact Backup: Name: Jaume Garcia López, Dr.; Phone Number: +34935866200; Email: info@bbraun.com

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Hospital Clinic De Barcelona
      • Contact: Dulce Momblán García, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Dulce Momblán García, Dr., Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: esophageal cancer; esophagectomy; anastomotic leakage; endoluminal vacuum therapy; abdominal and cardiac surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Anastomotic Leak; Esophageal Neoplasms
• Other Study ID Numbers: AAG-O-H-2209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No