OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Anastomotic Leak Esophagus Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05713955
• Other study ID #: BC-09974
• Status: Withdrawn
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Esophagus

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absence of anastomotic leak within 30 days post operatively
Secondary	mortality	in hospital mortality	from surgery until 30 days post operative
Secondary	sepsis	in hospital sepsis	from surgery until 30 day post operative
Secondary	pneumonia	in hospital pneumonia	from surgery until 30 day post operative
Secondary	late anastomotic leakage	late anastomotic leakage (ECCG type I, II and III)	from surgery until 90 days post operative
Secondary	stricture	stricture of the esophagogastric anastomosis	from surgery until 1 year post operative
Secondary	inflammation WBC	post operative inflammation (WBC)	from date of randomisation to postoperative day 5
Secondary	inflammation CRP	post operative inflammation (CRP)	from date of randomisation to postoperative day 5
Secondary	ICU stay	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
Secondary	hospital stay	total hospital stay	from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
Secondary	thoracic drainage volume	Volume of thoracic drain	from surgery until removal of thoracic drain within the first week postoperative
Secondary	thoracic drainage duration	duration of thoracic drain	from surgery until removal of thoracic drain within the first week postoperative