Universität zu Köln

van der Veen, A., Schiffmann, L. M., de Groot, E. M., Bartella, I, de Jong, P. A., Borggreve, A. S., Brosens, L. A. A., Dos Santos, D. Pinto, Fuchs, H., Ruurda, J. P., Bruns, C. J., van Hillegersberg, R. and Schroeder, W. (2022). The ISCON-trial protocol: laparoscopic ischemic conditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications. BMC Cancer, 22 (1). LONDON: BMC. ISSN 1471-2407

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Abstract

Background: Anastomotic leakage is the most important surgical complication following esophagectomy. A major cause of leakage is ischemia of the gastric tube that is used for reconstruction of the gastrointestinal tract. Generalized cardiovascular disease, expressed by calcifications of the aorta and celiac axis stenosis on a pre-operative CT scan, is associated with an increased risk of anastomotic leakage. Laparoscopic ischemic conditioning (ISCON) aims to redistribute blood flow and increase perfusion at the anastomotic site by occluding the left gastric, left gastroepiploic and short gastric arteries prior to esophagectomy. This study aims to assess the safety and feasibility of laparoscopic ISCON in selected patients with esophageal cancer and concomitant arterial calcifications. Methods: In this prospective single-arm safety and feasibility trial based upon the IDEAL recommendations for surgical innovation, a total of 20 patients will be included recruited in 2 European high-volume centers for esophageal cancer surgery. Patients with resectable esophageal carcinoma (cT1-4a, N0-3, M0) with major calcifications of the thoracic aorta accordingly to the Uniform Calcification Score (UCS) or a stenosis of the celiac axis accordingly to the modified North American Symptomatic Carotid Endarterectomy Trial (NASCET) score on preoperative CT scan, who are planned to undergo esophagectomy are eligible for inclusion. The primary outcome variables are complications grade 2 and higher (Clavien-Dindo classification) occurring during or after laparoscopic ISCON and before esophagectomy. Secondary outcomes include intra- and postoperative complications of esophagectomy and the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography. Discussion: We hypothesize that in selected patients with impaired vascularization of the gastric tube, laparoscopic ISCON is feasible and can be safely performed 12-18days prior to esophagectomy. Depending on the results, a randomized controlled trial will be needed to investigate whether ISCON leads to a lower percentage and less severe course of anastomotic leakage in selected patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code van der Veen, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schiffmann, L. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED de Groot, E. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bartella, I UNSPECIFIED UNSPECIFIED UNSPECIFIED de Jong, P. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Borggreve, A. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brosens, L. A. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dos Santos, D. Pinto UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuchs, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruurda, J. P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bruns, C. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED van Hillegersberg, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schroeder, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-676095
DOI:	10.1186/s12885-022-09231-x
Journal or Publication Title:	BMC Cancer
Volume:	22
Number:	1
Date:	2022
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1471-2407
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language COMPLICATIONS; INCREASES; RISK Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/67609