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Endoluminal vakuumterapi for at forhindre anastomotisk lækage efter esophagektomi på grund af esophageal cancer (ESPY)

17. september 2026 opdateret af: Aesculap AG

Prospektiv, multicenter, eksplorativ og observationel enarmsundersøgelse til evaluering af forebyggende endoluminal vakuumterapi for at forhindre anastomotisk lækage efter esophagektomi på grund af 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

44

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Eso-SPONGE®

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

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

Andre navne:
  • endoluminal vakuumterapi (EVT) enhed

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of patients with anastomotic leakage
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comprehensive Complication Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aesculap AG

Samarbejdspartnere

B.Braun Surgical SA

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. oktober 2024

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

16. oktober 2023

Først indsendt, der opfyldte QC-kriterier

20. oktober 2023

Først opslået (Faktiske)

24. oktober 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AAG-O-H-2209

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Ingen

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