Abstract
BackgroundAnastomotic 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.MethodsIn 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.DiscussionWe 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 registrationClinicaltrials.gov, NCT03896399. Registered 4 January 2019.
Highlights
Anastomotic leakage is the most important surgical complication following esophagectomy
Reduced blood flow may lead to impaired healing of the anastomosis and could result in anastomotic leakage
The ischemic conditioning (ISCON) trial is a safety and feasibility study aiming to stimulate the vascularisation of the gastric conduit prior to the esophagectomy in selected patients
Summary
Anastomotic leakage is the most important surgical complication following esophagectomy. 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. Transthoracic esophagectomy with 2-field lymphadenectomy is the standard of surgical care for patients with esophageal cancer [1]. The reconstruction of choice is a gastric tube with intrathoracic (Ivor-Lewis) or cervical esophagogastrostomy (McKeown). This gastric tube is perfused only by the right gastroepiploic artery, as all other gastric arteries are ligated during gastric mobilization. This is associated with severe change of microcirculation in the gastric tube, reducing gastric perfusion up to 50% [2,3,4,5]. Some risk factors have been identified, such as severe comorbidity, diabetes mellitus, smoking status, radiation field and cervical anastomosis [7, 8]
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