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.

Status Withdrawn

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Esophagus

• NCT number: NCT05713955
• Study type: Interventional
• Source: University Hospital, Ghent
• Status: Withdrawn
• Phase: N/A
• Start date: January 9, 2024
• Completion date: July 1, 2028