Improving outcomes in esophageal cancer surgery using advanced imaging techniques
Assessment of Graft Perfusion and Oxygenation for Improved Outcome in Esophageal Cancer Surgery
NA · University Hospital, Ghent · NCT03587532
This study is testing if a special imaging technique can help doctors make sure the stomach graft gets enough blood during esophageal cancer surgery to reduce complications afterward.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Ghent) |
| Trial ID | NCT03587532 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of indocyanine green angiography to assess graft perfusion and oxygenation during esophagectomy for esophageal cancer. By utilizing near-infrared fluorescence imaging, the research aims to quantify tissue blood flow and volume at the anastomotic site, addressing the high risk of anastomotic leakage. The study will compare these imaging-based perfusion parameters with traditional hemodynamic evaluations to validate their effectiveness. The goal is to establish a reliable method for ensuring adequate perfusion of the stomach graft, potentially reducing postoperative complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 scheduled for elective minimally invasive Ivor Lewis esophagectomy.
Not a fit: Patients with known hypersensitivity to indocyanine green or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of anastomotic leakage and improve surgical outcomes for patients undergoing esophagectomy.
How similar studies have performed: While the use of indocyanine green angiography is emerging, this specific application in esophageal cancer surgery is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent
- University Hospital — Ghent, Belgium (RECRUITING)
Study contacts
- Study coordinator: Elke Van Daele, MD
- Email: elke.vandaele@uzgent.be
- Phone: +323320829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anastomotic Leak, Esophageal Cancer, esophagectomy, indocyanine green, near infrared fluorescence