Clinical trials

Although advances in drug-eluting stents (DES) have substantially reduced the risk of coronary in-stent restenosis (ISR) and the need for target lesion revascularisation (TLR), ISR persists. There are several treatment options for ISR (conventional balloon angioplasty, cutting or scoring balloons, drug-coated balloons, repeat DES implantation or bypass surgery). Coronary imaging is mandatory to perform PCI on ISR. Optimal coherence tomography (OCT) is an excellent option to guide PCI, but its role in ISR-PCI remains unclear. The INSIDE OCT Trial aims to compare the acute performance of PCI for ISR, either guided by OCT and angiography or by angiography alone.

This is a nationwide prospective observational study to assess the overall clinical anastomotic leakage rate after right hemicolectomy for cancer, to detect the independent risk factors for AL, and to develop a clinical prediction model to estimates of the probability of the occurrence of an AL after surgery. Since this is a multicenter prospective study, the Division of Surgical Oncology and Digestive Surgery from the University of Turin, Department of Oncology, AOU San Luigi Gonzaga di Orbassano will be the Coordinator Center of the study, Ethics committee approves will be requested before the implementation of this study. Italian high-volume colorectal surgery centers members of SICO (The Italian Society of Oncological Surgery) have agreed to participate as collaborators of this study, notification and revision from their local ethics committee will be requested as well. A certified general surgeon with a large experience in the preoperative, operative, and postoperative management of patients with colorectal cancer has been identified to coordinate the study in each center. Id information of the potential collaborators is specified in the section "Trial Setting". Once the study is activated, eligible patients (or a representative) must provide written, informed consent before any study procedures occur. No intervention or modification of the habitual clinical practice is planned All data will enter into a database provided by the promoting center. There are three main sections of data collection for each patient: * Preoperative: baseline, disease and demographics. * Operative: details about the surgery, anastomosis construction and enterotomy closure. * Follow-up: outcomes data about the early (within 30 postoperative day) and late postoperative course (31 th - 60th postoperative day) and pathology report. The definition of AL is based on the presence of clinical signs (pain, fever, tachycardia, peritonitis, feculent or enteric drainage, purulent drainage, postoperative ileus, abscess, septicemia, and/or organ failure) with radiographic signs (fluid collections, gas containing collections at CT scan) suggestive of AL and-or intraoperative or autopsy findings (gross enteric spillage, anastomotic disruption). The absence of AL will be assumed by a normal postoperative course and the absence of symptoms suggestive of AL with or without radiologic confirmation.

Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Based on the concerns about the actual low strength of evidence of the efficacy of NAC on survival of proper gastric cancer treated with adequate D2 gastrectomy as compared to the results of optimal upfront surgery (S), and considering the actual difficulties of additional RCTs, the aim of this study is to assess the non-inferiority of upfront surgery alone with optimal D2 dissection compared to NAC regimens followed by surgery. Methods: This is a nationwide Multicenter observational retrospective study with matched comparison of two therapeutic strategies (NAC vs S). We will include patients with cT\>2, every cN M0, or with every T and N+ M0, histologically proven adenocarcinoma of the stomach, submitted either to pre- or peri-operative treatment and D2 gastrectomy or to upfront D2 gastrectomy, between January 2012 and December 2019, followed by adjuvant treatment when recommended. All patients matching the inclusion/exclusion criteria will be registered into the study and classified into one of the two arms: a, patients who underwent pre- or perioperative treatment and D2 gastrectomy (NAC) or b, patients submitted to upfront D2 gastrectomy (S). Given the results reported in the "FLOT" trial, a 3-years OS of 55% in the control arm (NAC) was assumed. Three-year OS in the experimental arm (S) was assumed to be 47.4% under the null hypothesis of inferiority and 55% under the alternative hypothesis of non-inferiority. A sample size of 684 patients (342 in each arm) achieves 80% power to detect a non-inferiority margin Hazard Ratio of 1.25

The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting. Nowadays, no studies compare the Reverse-TAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.