دورية أكاديمية

The ISCON-trial protocol: laparoscopic ischemic conditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications

التفاصيل البيبلوغرافية
العنوان: The ISCON-trial protocol: laparoscopic ischemic conditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications
المؤلفون: A. van der Veen, L. M. Schiffmann, E. M. de Groot, I. Bartella, P. A. de Jong, A. S. Borggreve, L. A. A. Brosens, D. Pinto Dos Santos, H. Fuchs, J. P. Ruurda, C. J. Bruns, R. van Hillegersberg, W. Schröder
المصدر: BMC Cancer, Vol 22, Iss 1, Pp 1-8 (2022)
بيانات النشر: BMC, 2022.
سنة النشر: 2022
المجموعة: LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
مصطلحات موضوعية: Esophagectomy, Ischemic preconditioning, ISCON, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
الوصف: 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 12–18 days 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. Trial registration Clinicaltrials.gov, NCT03896399 . Registered 4 January 2019.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1471-2407
Relation: https://doaj.org/toc/1471-2407
DOI: 10.1186/s12885-022-09231-x
URL الوصول: https://doaj.org/article/7803c8092f65496cad369c23145d6a10
رقم الأكسشن: edsdoj.7803c8092f65496cad369c23145d6a10
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:14712407
DOI:10.1186/s12885-022-09231-x