Clinical trial NCT05713955: 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, a Phase II Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Anastomotic Leak Esophagus
Keywords: anastomotic leakage
esophageal cancer surgery
autologous biomatrix
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Vivostat
First posted: 2023-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic leak
timeFrame: Absence of anastomotic leak within 30 days post operatively
Secondary outcomes:
measure: mortality
timeFrame: from surgery until 30 days post operative
measure: sepsis
timeFrame: from surgery until 30 day post operative
measure: pneumonia
timeFrame: from surgery until 30 day post operative
measure: late anastomotic leakage
timeFrame: from surgery until 90 days post operative
measure: stricture
timeFrame: from surgery until 1 year post operative
measure: inflammation WBC
timeFrame: from date of randomisation to postoperative day 5
measure: inflammation CRP
timeFrame: from date of randomisation to postoperative day 5
measure: ICU stay
timeFrame: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
measure: hospital stay
timeFrame: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
measure: thoracic drainage volume
timeFrame: from surgery until removal of thoracic drain within the first week postoperative
measure: thoracic drainage duration
timeFrame: from surgery until removal of thoracic drain within the first week postoperative
measure: intra-operative checklist
timeFrame: peroperative
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East-Flanders
Study officials:
affiliation: UZ Gent
name: Piet Pattyn
role: PRINCIPAL_INVESTIGATOR
References:
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.