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NCT Number: NCT05713955

OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

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.

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Key information

Conditions

Anastomotic Leak Esophagus Anastomotic Leak Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

Obsidian

Device

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

Primary outcomes

  1. Anastomotic leak

    Time frame: 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

Secondary outcomes

  1. mortality

    Time frame: from surgery until 30 days post operative

    in hospital mortality

  2. sepsis

    Time frame: from surgery until 30 day post operative

    in hospital sepsis

  3. pneumonia

    Time frame: from surgery until 30 day post operative

    in hospital pneumonia

  4. late anastomotic leakage

    Time frame: from surgery until 90 days post operative

    late anastomotic leakage (ECCG type I, II and III)

  5. stricture

    Time frame: from surgery until 1 year post operative

    stricture of the esophagogastric anastomosis

  6. inflammation WBC

    Time frame: from date of randomisation to postoperative day 5

    post operative inflammation (WBC)

  7. inflammation CRP

    Time frame: from date of randomisation to postoperative day 5

    post operative inflammation (CRP)

  8. ICU stay

    Time frame: 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

  9. hospital stay

    Time frame: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months

    total hospital stay

  10. thoracic drainage volume

    Time frame: from surgery until removal of thoracic drain within the first week postoperative

    Volume of thoracic drain

  11. thoracic drainage duration

    Time frame: from surgery until removal of thoracic drain within the first week postoperative

    duration of thoracic drain

  12. intra-operative checklist

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hanne Vanommeslaeghe

CONTACT

[email protected]

+3293325945

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Vivostat

Registry information

Official study title

Evaluation of Effectiveness and Safety of Autologous BioMatrix OBSiDiAN to Enhance a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy, a Phase II Study.

Acronym: Obsidian ph II

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 6, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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