ISCON trial - Laparoscopic ISchemic CONditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications
Completed
- Conditions
- Esophageal cancer100179901001799810003216
- Registration Number
- NL-OMON50061
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Patients with resectable esophageal carcinoma (cT1-4a, N0-3, M0) with *major
calcifications* of the thoracic aorta (UCS) or stenosis of the celiac axis
(modified NASCET score) on preoperative CT scan, who are planned to undergo
transthoracic of transhiatal esophagectomy.
Exclusion Criteria
Not able to undergo study treatment (surgery).
Metastatic disease (M1)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>all complications grade 2 and higher (Clavien-Dindo classification) occurring<br /><br>during or after operation 1 (laparoscopic ISCON) and before operation 2<br /><br>(esophagectomy).</p><br>
- Secondary Outcome Measures
Name Time Method <p>secondary outcomes with regard to operation 1 (laparoscopic ISCON) are the<br /><br>duration of the procedure, blood loss, day of discharge postoperatively and<br /><br>grade 1 complications. Secondary outcomes with regard to operation 2<br /><br>(esophagectomy) are anastomotic leakage rate, all other grade *3b complications<br /><br>and 30 day mortality. Further secondary endpoints are the induction of<br /><br>angiogenesis by biomarkers of microcirculation and redistribution of blood flow<br /><br>by measurement of indocyanine green (ICG) fluorescence angiography. </p><br>