Esophageal Cancer Clinical Trial
— ISCONOfficial title:
Laparoscopic Ischemic Conditioning Prior to Esophagectomy in Patients With Esophageal Cancer and Arterial Calcifications
This is a two center phase II prospective single-arm safety and feasibility trial for 20 patients with resectable esophageal carcinoma with an increased risk for anastomotic leakage, as based upon UCS and NASCET calcification scores on pre-op CT-scan. In these patients, laparoscopic ischemic conditioning is performed 12-18 days before an Ivor-Lewis esophagectomy. The primary outcome is all complications grade 2 and higher (Clavien-Dindo classification) occurring during or after the laparoscopic ischemic conditioning. Secondary outcomes are complications after the esophagectomy, and the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Histologically proven adenocarcinoma (AC) or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ) - Planned to undergo transthoracic esophagectomy or transhiatal esophagectomy - Preoperative computed tomography (CT) - Vascular arterial changes: "major calcifications" of the thoracic aorta according to the "Uniform calcification score" (UCS) and or a stenosis of the celiac axis according to the "modified NASCET score". (Appendix 1 and 2) (7,17) - ASA I-III - European Clinical Oncology Group (ECOG) performance status of 0,1 or 2 - Age > 17 - Written informed consent Exclusion criteria: - Not able to undergo study treatment. - Metastatic disease (M1) |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Cologne | Cologne | North Rhine-Westphalia |
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | University Hospital of Cologne |
Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with a grade 2 or higher complication after laparoscopic ischemic conditioning | Complications grade 2 and higher (Clavien-Dindo classification) | Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days. | |
Secondary | Number of participants with a grade 1 complication after operation 1 (laparoscopic ISCON) | Grade 1 complications after operation 1 (laparoscopic ISCON) | Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days. | |
Secondary | Duration of operation 1 (laparoscopic ISCON) | Duration of operation 1 (laparoscopic ISCON) | During operation 1 | |
Secondary | Bloodloss during operation 1 (laparoscopic ISCON) | Bloodloss during operation 1 (laparoscopic ISCON) | During operation 1 | |
Secondary | Day of discharge after operation 1 (laparoscopic ISCON) | Day of discharge after operation 1 (laparoscopic ISCON) | After operation 1, usually on the third post-operative day | |
Secondary | Number of participants with anastomotic leakage after operation 2 (esophagectomy) | Anastomotic leakage after operation 2 (esophagectomy) | Within 30 days after operation 2 | |
Secondary | Number of participants with grade 3b or higher complications after operation 2 (esophagectomy) | Grade 3b (Clavien-Dindo classification) or higher complications after operation 2 (esophagectomy) | Within 30 days after operation 2 | |
Secondary | Number of participants with 30 day mortality after operation 2 (esophagectomy) | 30 day mortality after operation 2 (esophagectomy) | Within 30 days after operation 2 | |
Secondary | Induction of angiogenesis in tissue | Paraffin embedded sections (10µm) will be stained by immunohistochemistry against CD31 (vessel density) or smooth-muscle-actin positive pericytes to characterize vascularity | Biopsies are taken at the start, or within 24 hours of operation 1 and operation 2. In addition, the anastomoc donut or tip of gastric tube is collected during operation 2 (esophagectomy) after formation of the anastomosis. | |
Secondary | Induction of angiogenesis by biomarkers of microcirculation | A cytokine profile will be measured in the peripheral blood, consisting of VEGF, IL-8, IL-6, TNF-alpha and Ang-2 | Peripheral blood is taken at the start, or within 24 hours of operation 1 | |
Secondary | Redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography | Redistribution of blood flow by measurement of indocyanine green (ICG) | During operation 1 and during operation 2 (esophagectomy) |
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