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OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Primary Purpose

Anastomotic Leak Esophagus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Obsidian
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anastomotic Leak Esophagus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 oesophageal carcinoma scheduled for elective minimally invasive or open Ivor Lewis esophagectomy 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 (American Society of Anesthesiologists physical status classification system: 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. Hemoglobin level < 8 g/dL Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    study group

    standard group

    Arm Description

    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.

    The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. A methylene blue leakage test or other leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected.

    Outcomes

    Primary Outcome Measures

    Anastomotic leak
    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 Outcome Measures

    mortality
    in hospital mortality
    sepsis
    in hospital sepsis
    pneumonia
    in hospital pneumonia
    late anastomotic leakage
    late anastomotic leakage (ECCG type I, II and III)
    stricture
    stricture of the esophagogastric anastomosis
    inflammation WBC
    post operative inflammation (WBC)
    inflammation CRP
    post operative inflammation (CRP)
    ICU stay
    length of ICU stay
    hospital stay
    total hospital stay
    thoracic drainage volume
    Volume of thoracic drain
    thoracic drainage duration
    duration of thoracic drain

    Full Information

    First Posted
    November 8, 2021
    Last Updated
    July 31, 2023
    Sponsor
    University Hospital, Ghent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05713955
    Brief Title
    OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
    Official Title
    Evaluation of Effectiveness and Safety of Autologous BioMatrix OBSiDiAN to Enhance a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy in a Multicentre Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2027 (Anticipated)
    Study Completion Date
    July 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Ghent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.
    Detailed Description
    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 oesophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis. SAMPLE SIZE A total of 600 patients will be included in the study. 300 patients in each study arm. ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in this centre, University Hospital Ghent, with inclusion of patients in other European high volume centers, we predict an enrolment period of 4 years. PRIMARY ENDPOINT Anastomotic leak type I, II and III within 30 days post operatively. Anastomotic leak is defined according to the Esophagectomy Complications Consensus Group (ECCG).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anastomotic Leak Esophagus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Design : An international, multicentre randomized controlled trial evaluating the effectiveness and safety of autologous BioMatrix OBSiDiAN in reducing the incidence of anastomotic leaks following Ivor Lewis esophagectomy for oesophageal carcinoma. Randomization : Eligible patients will randomized in a 1:1 allocation to either the autologous BioMatrix OBSiDiAN group (study group) or the standard of care group (control group). Procedure: For both the control group and intervention group: A standard laparoscopic, robotic or open Ivor Lewis esophagectomy with an intrathoracic end-to-side stapled esophagogastric anastomosis. For the intervention group: After the abdominal fase and randomisation, a 120 ml blood sample will be drawn from the patient and put in the Vivostat® processor unit to make Obsidian. At the time of the anastomosis Obsidian will be applied between and around the esophagogastric anastomosis
    Masking
    Participant
    Masking Description
    Eligible patients will be randomized in a 1:1 allocation to either the autologous BioMatrix OBSiDiAN group (study group) or the standard of care group (control group). Subjects will be randomized at the ending of the abdominal phase of the surgery. In the event, that a potential subject fails the intra-operative criteria, an intention-to-treat protocol is followed. Given the nature of the study, blinding the surgeon to the treatment is not possible. The patient will be blinded for the study.
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    standard group
    Arm Type
    No Intervention
    Arm Description
    The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. A methylene blue leakage test or other leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected.
    Intervention Type
    Device
    Intervention Name(s)
    Obsidian
    Intervention Description
    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 Outcome Measure Information:
    Title
    Anastomotic leak
    Description
    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
    Time Frame
    Absence of anastomotic leak within 30 days post operatively
    Secondary Outcome Measure Information:
    Title
    mortality
    Description
    in hospital mortality
    Time Frame
    from surgery until 30 days post operative
    Title
    sepsis
    Description
    in hospital sepsis
    Time Frame
    from surgery until 30 day post operative
    Title
    pneumonia
    Description
    in hospital pneumonia
    Time Frame
    from surgery until 30 day post operative
    Title
    late anastomotic leakage
    Description
    late anastomotic leakage (ECCG type I, II and III)
    Time Frame
    from surgery until 90 days post operative
    Title
    stricture
    Description
    stricture of the esophagogastric anastomosis
    Time Frame
    from surgery until 1 year post operative
    Title
    inflammation WBC
    Description
    post operative inflammation (WBC)
    Time Frame
    from date of randomisation to postoperative day 5
    Title
    inflammation CRP
    Description
    post operative inflammation (CRP)
    Time Frame
    from date of randomisation to postoperative day 5
    Title
    ICU stay
    Description
    length of 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
    Title
    hospital stay
    Description
    total 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
    Title
    thoracic drainage volume
    Description
    Volume of thoracic drain
    Time Frame
    from surgery until removal of thoracic drain within the first week postoperative
    Title
    thoracic drainage duration
    Description
    duration of thoracic drain
    Time Frame
    from surgery until removal of thoracic drain within the first week postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 oesophageal carcinoma scheduled for elective minimally invasive or open Ivor Lewis esophagectomy 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 (American Society of Anesthesiologists physical status classification system: 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. Hemoglobin level < 8 g/dL Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanne Vanommeslaeghe
    Phone
    +3293325945
    Email
    hanne.vanommeslaeghe@uzgent.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Piet Pattyn
    Organizational Affiliation
    UZ Gent
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30527497
    Citation
    Plat VD, Bootsma BT, van der Wielen N, van der Peet DL, Daams F. Autologous Activated Fibrin Sealant for the Esophageal Anastomosis: A Feasibility Study. J Surg Res. 2019 Feb;234:49-53. doi: 10.1016/j.jss.2018.08.049. Epub 2018 Sep 27.
    Results Reference
    result

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    OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

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