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Endoluminale vacuümtherapie om anastomotische lekkage na slokdarmresectie als gevolg van slokdarmkanker te voorkomen (ESPY)

5 november 2026 bijgewerkt door: Aesculap AG

Prospectieve, multicenter, verkennende en observationele eenarmige studie ter evaluatie van preventieve endoluminale vacuümtherapie ter voorkoming van anastomotische lekkage na slokdarmresectie als gevolg van slokdarmkanker

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

44

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Spanje
    • Catalonia
      • Barcelona, Catalonia, Spanje, 08036
        • Hospital Clinic de Barcelona

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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)

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Eso-SPONGE®

endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer
Apparaat: Eso-SPONGE®

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

Andere namen:
  • apparaat voor endoluminale vacuümtherapie (EVT).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of patients with anastomotic leakage
Tijdsspanne: throughout the duration of the study (until last follow-up at postoperative day 90)

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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Comprehensive Complication Index
Tijdsspanne: Postoperative day 30 and day 90

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

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
Tijdsspanne: Postoperative day 30 and day 90

The different grades of postoperative ischemia at Visit 1, Visit 2 and Visit 3
Postoperative day 30 and day 90
Rate of postoperative mortality
Tijdsspanne: Postoperative day 30 and day 90

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

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
Tijdsspanne: until discharge (approximately 10 days postoperatively)

time elapsed until reaching the "fit for discharge criteria" regarding investigational device application
until discharge (approximately 10 days postoperatively)
Re-admissions to hospital
Tijdsspanne: throughout the duration of the study (until last follow-up at postoperative day 90)

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

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

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

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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Aesculap AG

Medewerkers

B.Braun Surgical SA

Onderzoekers

  • Hoofdonderzoeker: Dulce Momblán García, Dr., Hospital Clinic of Barcelona

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 oktober 2024

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

16 oktober 2023

Eerst ingediend dat voldeed aan de QC-criteria

20 oktober 2023

Eerst geplaatst (Werkelijk)

24 oktober 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AAG-O-H-2209

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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