OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Phase 2Not Yet RecruitingNCT05713955

University Hospital, Ghent90 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Absence of anastomotic leak within 30 days post operatively

Secondary Outcomes

mortality

in hospital mortality

Time frame: from surgery until 30 days post operative

sepsis

in hospital sepsis

Time frame: from surgery until 30 day post operative

pneumonia

in hospital pneumonia

Time frame: from surgery until 30 day post operative

late anastomotic leakage

late anastomotic leakage (ECCG type I, II and III)

Time frame: from surgery until 90 days post operative

stricture

stricture of the esophagogastric anastomosis

Time frame: from surgery until 1 year post operative

inflammation WBC

post operative inflammation (WBC)

Time frame: from date of randomisation to postoperative day 5

inflammation CRP

post operative inflammation (CRP)

Time frame: from date of randomisation to postoperative day 5

ICU stay

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

hospital stay

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

thoracic drainage volume

Volume of thoracic drain

Time frame: from surgery until removal of thoracic drain within the first week postoperative

thoracic drainage duration

duration of thoracic drain

Time frame: from surgery until removal of thoracic drain within the first week postoperative

intra-operative checklist

* Hb \> 8 g/dL * No tension on the anastomosis * No torsion on the anastomosis * Complete visibility of the anastomosis * Dry operation area * Application on the gastric stump * Application area of 2 cm proximal and distal of the anastomosis * Application completely covering the anastomosis * Visible white layer of fibrin sealant * Dry for 30 seconds

Time frame: peroperative