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Endoluminal vakuumterapi for å forhindre anastomotisk lekkasje etter esofagektomi på grunn av spiserørskreft (ESPY)

17. september 2026 oppdatert av: Aesculap AG

Prospektiv, multisenter, utforskende og observasjonsstudie med én arm for å evaluere forebyggende endoluminal vakuumterapi for å forhindre anastomotisk lekkasje etter esofagektomi på grunn av 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

44

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Eso-SPONGE®

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

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

Andre navn:
  • endoluminal vakuumterapi (EVT) enhet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Aesculap AG

Samarbeidspartnere

B.Braun Surgical SA

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. oktober 2024

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

16. oktober 2023

Først innsendt som oppfylte QC-kriteriene

20. oktober 2023

Først lagt ut (Faktiske)

24. oktober 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AAG-O-H-2209

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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