Assessment of Graft Perfusion and Oxygenation for Improved Outcome in Esophageal Cancer Surgery

Launched by UNIVERSITY HOSPITAL, GHENT · Jul 13, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to assess blood flow in the stomach graft used during surgery for esophageal cancer. After patients undergo a procedure called minimally invasive Ivor Lewis esophagectomy, they may experience complications like anastomotic leakage, which can be quite serious. This trial aims to see if a special imaging technique called indocyanine green angiography (ICGA) can help doctors better understand blood flow to the graft and potentially reduce the risk of complications.

To be eligible for this trial, participants need to be between 18 and 75 years old, scheduled for the Ivor Lewis esophagectomy, and willing to provide consent to join the study. Participants can expect to undergo the surgery as planned but will also have their graft perfusion assessed using the ICGA method. This study is important because it could lead to better outcomes for patients undergoing this type of surgery by providing doctors with more accurate information about blood flow to the graft, ultimately aiming to improve patient safety and recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pre- and intraoperatively
• • Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
• • Subjects scheduled for elective minimally invasive Ivor Lewis esophagectomy
• • Intrathoracic circular stapled esophago-gastric anastomosis
• Exclusion Criteria:
• • Preoperatively
• • Known hypersensitivity to ICG
• • Female patients who are pregnant or nursing
• • Participation in other studies involving investigational drugs or devices.
• • Use of Avastin™ (bevacizumab) or other anti vascular endothelial growth factor (VEGF) agents within 30 days prior to surgery
• • Intra-operatively
• • Intra-operative findings that may preclude conduct of the study procedures
• • Anastomosis performed differently than the standard of care
• • Excessive bleeding (\>500 ml) prior to anastomosis