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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

After the esophagectomy, the stomach is most commonly used to restore continuity of the upper gastro-intestinal tract. The esophagogastric anastomosis is prone to serious complications such as anastomotic leakage (AL) The reported incidence of AL after esophagectomy ranges from 5%-20%. The AL associated mortality ranges from 18-40% compared with an overall in-hospital mortality of 4-6%. The main cause of AL is tissue hypoxia, which results from impaired perfusion of the pedicle stomach graft. Clinical judgment is unreliable in determining anastomotic perfusion. Therefore, an objective, validated, and reproducible method to evaluate tissue perfusion at the anastomotic site is urgently needed. Indocyanine green angiography (ICGA) is a near infrared fluorescent (NIRF) perfusion imaging using indocyanine green (ICG). ICGA is a safe, easy and reproducible method for graft perfusion analysis, but it is not yet calibrated. The purpose of this study is to evaluate the feasibility of quantification of ICGA to assess graft perfusion and its influence on AL in patients after minimally invasive Ivor Lewis esophagectomy (MIE) for cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Belgium
University Hospital
RECRUITING
Ghent
Contact Information
Primary
Elke Van Daele, MD
elke.vandaele@uzgent.be
+323320829
Backup
Yves Van Nieuwenhove, MD, PhD
Yves.Vannieuwenhove@uzgent.be
+3293324893
Time Frame
Start Date: 2021-12-13
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 70
Treatments
Experimental: Indocyanine Green Angiography
ICG based angiography after creation of the stomach graft and after thoracic pull-up of the graft. Dynamic digital images will be obtained starting immediately after intravenous bolus administration of 0.5 mg/kg of ICG.
Related Therapeutic Areas
Sponsors
Collaborators: Kom Op Tegen Kanker
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov