OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Phase 2

Not yet recruiting

• Conditions: Anastomotic Leak Esophagus

• Registration Number: NCT05713955
• Lead Sponsor: University Hospital, Ghent

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).

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Study Start: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2028-04-01
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Anastomotic leak	Absence of anastomotic leak within 30 days post operatively	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

Secondary Outcome Measures

Name	Time	Method
mortality	from surgery until 30 days post operative	in hospital mortality
inflammation WBC	from date of randomisation to postoperative day 5	post operative inflammation (WBC)
hospital stay	from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months	total hospital stay
thoracic drainage duration	from surgery until removal of thoracic drain within the first week postoperative	duration of thoracic drain
sepsis	from surgery until 30 day post operative	in hospital sepsis
pneumonia	from surgery until 30 day post operative	in hospital pneumonia
late anastomotic leakage	from surgery until 90 days post operative	late anastomotic leakage (ECCG type I, II and III)
stricture	from surgery until 1 year post operative	stricture of the esophagogastric anastomosis
inflammation CRP	from date of randomisation to postoperative day 5	post operative inflammation (CRP)
ICU stay	from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months	length of ICU stay
thoracic drainage volume	from surgery until removal of thoracic drain within the first week postoperative	Volume of thoracic drain
intra-operative checklist	peroperative	* 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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, East-Flanders, Belgium