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

Evaluation of gastric conduit perfusion with near infrared fluorescence imaging during esophagectomy: a pilot study - EGAPERF (Evaluation of GAstric conduit PERFusion

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46607

Enrollment

Registered

2018-03-08

Start date

2018-03-08

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
- Monitor the procedure time; the total time of the chirurgical procedure is measured. - Complications due to NIRF imaging with ICG	—

Countries

Netherlands

Outcome results