OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

NCT05713955 | Not Yet Recruiting Phase 2

• 1 other identifier: BC-09974
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Leak Esophagus

Keywords

anastomotic leakage; esophageal cancer surgery; autologous biomatrix

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• mortality

  from surgery until 30 days post operative

• sepsis

  from surgery until 30 day post operative

• pneumonia

  from surgery until 30 day post operative

• late anastomotic leakage

  from surgery until 90 days post operative

• stricture

  from surgery until 1 year post operative

Study Arms (1)

study group

EXPERIMENTAL

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.

Device: Obsidian

Interventions

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

study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Vivostat: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Related 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.

  PMID: 30527497 BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Piet Pattyn

  UZ Gent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne Vanommeslaeghe

CONTACT

+3293325945; hanne.vanommeslaeghe@uzgent.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: February 6, 2023
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

BE (1)