OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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

Первичные конечные точки

• Anastomotic leak [Срок оценки: Absence of anastomotic leak within 30 days post operatively]

Вторичные конечные точки (12)

• mortality [Срок оценки: from surgery until 30 days post operative]
• sepsis [Срок оценки: from surgery until 30 day post operative]
• pneumonia [Срок оценки: from surgery until 30 day post operative]
• late anastomotic leakage [Срок оценки: from surgery until 90 days post operative]
• stricture [Срок оценки: from surgery until 1 year post operative]
• inflammation WBC [Срок оценки: from date of randomisation to postoperative day 5]
• inflammation CRP [Срок оценки: from date of randomisation to postoperative day 5]
• ICU stay [Срок оценки: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months]
• hospital stay [Срок оценки: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months]
• thoracic drainage volume [Срок оценки: from surgery until removal of thoracic drain within the first week postoperative]
• thoracic drainage duration [Срок оценки: from surgery until removal of thoracic drain within the first week postoperative]
• intra-operative checklist [Срок оценки: peroperative]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• University Hospital Ghent — Ghent

Публикации

• 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. PMID 30527497

Идентификаторы

NCT: NCT05713955 · BC-09974

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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