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OBSiDiAN i en hæftet cirkulær esophagogastrisk anastomose efter Ivor Lewis esophagectomy (Obsidian ph II)

16. september 2026 opdateret af: University Hospital, Ghent

Evaluering af effektivitet og sikkerhed af autolog biomatrix OBSiDiAN til at forbedre en hæftet cirkulær esophagogastrisk anastomose efter Ivor Lewis esophagectomy i et multicenter randomiseret kontrolleret forsøg.

Oesophagectomy is very invasive surgery. A leakage at the level of the connection between oesophagus and stomach made during surgery causes a lot more problems and can lead to death. Studies show that the leakage rate sometimes goes up to 40 per cent. The chance of dying if you develop a leak after surgery is 15%, while the overall chance of dying during hospitalisation for this procedure is about 4%. We want to investigate whether the use of this new type of 'glue' (Obsidian®) can reduce the number of leaks. We invite you to participate in a clinical trial with the aim of investigating whether Obsidian® is safe and can reduce the number of leaks after oesophageal surgery in patients with oesophageal cancer. We want to apply a new type of 'glue', Obsidian®, at the level of the new connection between oesophagus and stomach.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

STUDY PRODUCT Autologous BioMatrix: Obsidian (medical device class III)

STUDY POPULATION Subjects ≥ 18 years and ≤ 75 years of age scheduled for elective Ivor Lewis esophagectomy for esophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis.

SAMPLE SIZE A total of 90 patients will be included in the study. ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in University Hospital Ghent, we predict an enrolment period of 3 years.

STUDY DURATON Considering a 3 years enrolment period and a 1 year follow up we predict a study duration of 4 years.

PRIMAIRY ANALYSIS

• Anastomotic leak within 30 days post operatively. Anastomotic leak type I, II and III is defined according to the Esophagectomy Complications Consensus Group (ECCG).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Belgien
    • East-Flanders
      • Ghent, East-Flanders, Belgien, 9000
      • Ghent, East-Flanders, Belgien, 9000
        • Ikke rekrutterer endnu
        • University Hospital Ghent
        • Kontakt:

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  1. Inclusion criteria Preoperatively

    • Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
    • Subjects with esophageal carcinoma (distal until Siewert II) scheduled for elective minimally invasive Ivor Lewis esophagectomy (cT1-4a,N0-3,M0).

    Intra-operatively

    - Intrathoracic circular stapled esophagogastric anastomosis

  2. Exclusion criteria preoperatively

    • Female patients who are pregnant or nursing
    • Participation in another study involving investigational drugs or devices.
    • Use of Avastin within 30 days prior to surgery
    • ASA IV (patient with severe systemic disease that is a constant threat to life)
    • Patients with other malignancies
    • Patients with previous esophageal or gastric surgery
    • Known hypersensitivity to batroxobin and tranexamic acid.
    • HB level < 8 g/dL
    • Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling.
    • Patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling
    • Patients on other platelet aggregation inhibitor therapies not able to stop using the platelet aggregation inhibitor therapies for 3 days before taking the blood sample.

Intra-operatively

  • Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …
  • Anastomosis preformed differently than the standard of care
  • Excessive bleeding (>500 ml) prior to anastomosis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: study group

For the study group, a unit of autologous BioMatrix OBSiDiAN will be produced. Blood sample (120ml) will be taken after randomization at the ending of the abdominal phase of the surgery. The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. Around 1-2ml of autologous BioMatrix OBSiDiAN will be applied on the distal/or proximal resection stump before the stapled anastomose will be created. After firing the standard circular device and creation of a functional anastomosis, a further 2.5-3ml OBSiDiAN must be applied circumferentially on the outside on the anastomosis. Once application is completed, a 30 seconds waiting period is required before putting the esophagus back into the surgical field (study specific). A methylene blue leakage test or other leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected or the completed procedure has to be done again.
Enhed: Obsidian

To create OBSiDiAN BioMatrix, 120 ml of the the patient's blood is added to the processing unit. The Vivostat® processor unit heats, separates, centrifugates to get the plasma. Batroxobin is added. After again processing, the result is an OBSiDian syringe filled with BioMatrix Obsidian®ASG. This will be applied on the anastomosis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anastomotic leak
Tidsramme: Absence of anastomotic leak within 30 days post operatively

Anastomotic leak defined according to the ECCG guidelines type I: local defect requiring no change in therapy or treated medicallly or with dietary modifications type II: localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening and packing or incision type III: localized defect requiring surgical therapy
Absence of anastomotic leak within 30 days post operatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mortality
Tidsramme: from surgery until 30 days post operative

in hospital mortality
from surgery until 30 days post operative
sepsis
Tidsramme: from surgery until 30 day post operative

in hospital sepsis
from surgery until 30 day post operative
pneumonia
Tidsramme: from surgery until 30 day post operative

in hospital pneumonia
from surgery until 30 day post operative
late anastomotic leakage
Tidsramme: from surgery until 90 days post operative

late anastomotic leakage (ECCG type I, II and III)
from surgery until 90 days post operative
stricture
Tidsramme: from surgery until 1 year post operative

stricture of the esophagogastric anastomosis
from surgery until 1 year post operative
inflammation WBC
Tidsramme: from date of randomisation to postoperative day 5

post operative inflammation (WBC)
from date of randomisation to postoperative day 5
inflammation CRP
Tidsramme: from date of randomisation to postoperative day 5

post operative inflammation (CRP)
from date of randomisation to postoperative day 5
ICU stay
Tidsramme: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months

length of ICU stay
from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
hospital stay
Tidsramme: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months

total hospital stay
from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
thoracic drainage volume
Tidsramme: from surgery until removal of thoracic drain within the first week postoperative

Volume of thoracic drain
from surgery until removal of thoracic drain within the first week postoperative
thoracic drainage duration
Tidsramme: from surgery until removal of thoracic drain within the first week postoperative

duration of thoracic drain
from surgery until removal of thoracic drain within the first week postoperative
intra-operative checklist
Tidsramme: peroperative
  • Hb > 8 g/dL
  • No tension on the anastomosis
  • No torsion on the anastomosis
  • Complete visibility of the anastomosis
  • Dry operation area
  • Application on the gastric stump
  • Application area of 2 cm proximal and distal of the anastomosis
  • Application completely covering the anastomosis
  • Visible white layer of fibrin sealant
  • Dry for 30 seconds
peroperative

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Ghent

Samarbejdspartnere

Vivostat

Efterforskere

  • Ledende efterforsker: Piet Pattyn, UZ Gent

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. juni 2025

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

8. november 2021

Først indsendt, der opfyldte QC-kriterier

1. februar 2023

Først opslået (Faktiske)

6. februar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BC-09974

Plan for individuelle deltagerdata (IPD)

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