Evaluation of gastric conduit perfusion with near infrared fluorescence imaging during esophagectomy: a pilot study

Completed

• Conditions: 10017990; esophageal cancer

• Registration Number: NL-OMON46607
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- Patients scheduled for a minimal invasive (or open) esophagectomy for esophageal cancer with a gastric conduit reconstruction
- Aged 18 years or older
- Signed informed consent.

Exclusion Criteria

- Known pregnancy or breastfeeding
- Known iodine, shellfish or ICG hypersensitivity
- Known hyper-thyroidism
- Known liver or renal insufficiency
- Unable to provide informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Visualization of the perfusion of the gastric conduit and wash-in and<br /><br>wash-out time of the ICG just before reconstruction of the anastomosis.<br /><br>- Visualization of the perfusion of the anastomotic site after reconstruction<br /><br>of the anastomosis, also measuring the wash-in and wash-out time of the ICG.<br /><br>- Postoperative anastomotic leakage. Anastomotic leakage is defined as clinical<br /><br>suspicion and confirmation by CT-scan of contrast, methylene blue, saliva or<br /><br>other ingested material into the drain or signs of anastomotic leakage during<br /><br>re-intervention or autopsy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Monitor the procedure time; the total time of the chirurgical procedure is<br /><br>measured.<br /><br>- Complications due to NIRF imaging with ICG </p><br>