SSD MED/18 - Chirurgia Generale

TITOLO DEL PROTOCOLLO

PATOLOGIE

trial monocentrico 'Drainage Fluid Biomarkers and Anastomotic Leakage in Colorectal Surgery. A Monocentric Prospective Observational Study (ALbiomarkers)'

Anastomotic leakage (AL) is one of the most feared intra-abdominal septic complications (IASC) after colorectal surgery. It is defined as the leak of intestinal content due to an anastomotic dehiscence. Incidence ranges from 2% to 20%. AL is usually associated to systemic inflammatory response, even if in some cases the presentation may be subclinical. Therefore, AL is suspected in patients with a strong inflammatory response and can be confirmed by imaging with contrast enhanced computed tomography (CT) scan or water-soluble contrast studies. Nevertheless, imaging has varying sensitivity and specificity and is usually performed once the patient has a clinical evidence, thus potentially delaying the correct timing for surgery. Despite several studies about this topic and the plenty of known risk factors as mentioned above, AL is still not easy to predict. Different tools other than imaging have been studied in order to make diagnosis of AL at an early stage, as the measurement of some biomarkers of inflammation in serum and in drainage fluid.

Biomarkers as white cell blood count (WBC), C-reactive protein (CRP), cytokines (e.g. TNFa, IL-6, IL-1b), markers of ischemia (e.g. lactate) and procalcitonin (PCT) have been used for an early detection of AL and other intra-abdominal septic complications. The primary aim of our study was to assess the role of drainage fluid CRP and lactate-dehydrogenase (LDH) in the early detection of anastomotic leakage.

Codice Clinical Trials: NCT04846283
Clinical Trials page: US ClinicalTrials.gov
First Posted: April 15, 2021

Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
Principal Investigator: Antonino Agrusa, Professor University of Palermo - Italy

trial monocentrico 'Radiologic Assessment in Complete Mesocolic Excision for Right Colon Cancer (RACOMERC) (RACOMERC)'

Colorectal surgery has made progressive advances in recent years related on one hand to the implementation of diagnostic methods that allow an early diagnosis of tumors and on the other hand to the development of therapeutic options based on laparoscopic surgery. In particular, multicenter clinical trials have shown that the laparoscopic approach to colorectal cancer had a comparable or even better outcomes in terms of perioperative complications and functional recovery of patients than traditional surgery. Complete Mesocolic Excision (CME) in right colonic resections is a surgical approach, of greater technical complexity, that appears to improve the oncological outcomes of these patients at the cost of an increased rate of complications. The highest rate of complications reported in the literature in patients undergoing CME was related to intraoperative bleeding due to the central vascular dissection that is performed. CT technological advances have made possible to perform CT angiography with multiplanar and three-dimensional reconstructions with the possibility of obtaining a detailed preoperative map of the vascular anatomy of these patients. CT scan was acquired immediately before contrast material injection and during arterial and venous phase. Arterial phase was obtained using the bolus tracking technique with an automated scan-triggering software. Image analysis was performed using multiplanar reformations (MPR), maximum intensity projection (MIP) and 3D volume rendering (VR) technique. The purpose of the CT was to identify three different parameters necessary for proper performance of CME and CVL and to compare preoperative observations with intraoperative evidence. All surgeries were performed by teams experienced in laparoscopic colorectal surgery. The investigators evaluated:- Fascia of Fredet; vascular structures; lymph nodes.

Codice Clinical Trials: NCT04834011
Clinical Trials page: US ClinicalTrials.gov
First Posted: April 6, 2021

Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
Principal Investigator: Antonino Agrusa, Professor University of Palermo - Italy

trial multicentrico 'Laparoscopic Hernia Defect Obliteration With ProFlor-E'

This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect. 

The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Codice Clinical Trials: NCT04718298
Clinical Trials page: US ClinicalTrials.gov

First Posted : August 31, 2018

Centro coordinatore: University of Cagliari
Principal Investigator: Giuseppe Amato, MD University of Cagliari

Principal Investigatore per il centro AOU Policlinico Paolo Giaccone: prof. Attilio Ignazio Lo Monte

trial monocentrico 'Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus'

Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.

Codice Clinical Trials: NCT01869231
Clinical Trials page: US ClinicalTrials.gov
First Posted: June 5, 2013

Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
Principal Investigator: Sebastiano Bonventre, Professor University of Palermo - Italy

trial monocentrico 'Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures'

Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fissures (AF). We aim to evaluate the effectiveness of a diet in curing AF and the clinical effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or wheat.

Codice Clinical Trials: NCT01637857
Clinical Trials page: US ClinicalTrials.gov
First Posted: July 11, 2012

Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
Principal Investigator: Sebastiano Bonventre, Professor University of Palermo - Italy

SSD MED/41 - Anestesiologia

TITOLO DEL PROTOCOLLO

PATOLOGIE

trial multicentrico 'Efficacia del rimpiazzo volemico con albumina e soluzioni bilanciate cristalloidi in pazienti con shock settico (studio albioss-balanced)'

Si tratta di un trial randomizzato controllato multicentrico fattoriale 2X2, approvato e supportato da AIFA, Eudract registrated.

Eudract number: 2018-001582-16
Eudract page: EU Clinical Trials Register

Codice Clinical Trials: NCT03654001
Clinical Trials page: US ClinicalTrials.gov

First Posted : August 31, 2018

Registro Studi Clinici Mario Negri

Gli obiettivi dello studio sono valutare se 1) la somministrazione di albumina in aggiunta a cristalloidi, rispetto all’utilizzo dei soli cristalloidi riduce la mortalità a 90 giorni (Obiettivo 1); l’utilizzo di soluzioni cristalloidi bilanciate (BAL) riduce la mortalità a 90 giorni o l’incidenza di insufficienza renale acuta, rispetto all’utilizzo di Soluzione Fisiologica (NS) (Obiettivo 2).

Centro coordinatore: IRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI - FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Principal Investigatore per il centro AOU Policlinico Paolo Giaccone: Dott. Andrea Cortegiani

SSD MED/49 - Scienze tecniche dietetiche applicate

TITOLO DEL PROTOCOLLO

PATOLOGIE

trial monocentrico 'BRCA Main Home Nutritional Intervention-random Study'

Women carrying harmful mutation in BRCA1 or BRCA2 gene are at higher risk to develop breast and/or ovarian cancer than the general population. Many observations lead to the hypothesis that breast cancer risk may be increased in women with elevated plasma insulin-like growth factor 1 (IGF-1) and insulin levels. Targeting the IGF system is therefore a promising anticancer therapy and a new tool for oncologists. Evidence from bio-gerontology research from our laboratories show that cycles of short-term fasting/starvation (STS) or low calorie diet can improve health span of laboratory animals, whose effect is partly mediated by reduced circulating IGF-1. Investigators in our group have demonstrated that protein consumption, especially animal proteins, increases IGF-1 level and is associated with elevated cancer risk in a US cohort ranging from age 50 to 65 (PMID: 26094889). It was also showed that alternating prolonged fasting and nutrient-rich medium extended yeast lifespan independently of the status of the established pro-longevity genes. Prolonged Fasting (PF) has also been shown in preliminary studies to decrease the side effects of chemotherapy, an effect now being tested in multiple larger randomized clinical trials (PMID: 26590477). The main hypothesis of this proposal is that a combination of protein restriction, fasting, fasting mimicking diet (FMD), and restriction of specific amino acids may be able to decrease cancer incidence in a cohort of people at high risk of developing tumors (BRCA1/2). Our group plan to verify the safety, effectiveness and impact of a specially formulated longevity dietary regimen (low protein fish- and plant-based) and of FMD repeated cycles on the levels of endogenous hormones in a cohort of people at increased cancer risk. Since the duration of the project will not give us the opportunity to directly measure cancer incidence in humans we will test: 1a) the variation of a number of widely recognized susceptibility biomarkers predictive of cancer incidence in a cohort human carriers of BRCA1/2 mutations in response to the dietary interventions; 1b) cancer incidence and progression in genetically engineered mice (K14Cre Brca1flox/flox Trp53+/flox and K14Cre Brca1+/flox Trp53-/- mice) predisposed to develop hereditary breast cancer in response to corresponding dietary interventions. Investigators will also test epigenetic alterations associated with these interventions in: 2a) DNA samples from muscle biopsies of a subgroup of humans; 2b) breast epithelial tissue in mice.

Codice Clinical Trials: NCT03570125
Clinical Trials page: US ClinicalTrials.gov

First Posted : June 26, 2018

Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
Principal Investigator: Mario Giuseppe Mirisola, PhD

BRCA1 Mutation

BRCA2 Mutation

SSD MED/06 - Oncologia Medica

TITOLO DEL PROTOCOLLO

PATOLOGIE

trial multicentrico 'Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma (ISG-MCS)'

Codice Clinical Trials: NCT04305548
Clinical Trials page: US ClinicalTrials.gov

First Posted : March 12, 2020

Centro coordinatore: Italian Sarcoma Group

Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS INT di Milano

Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD

Mesenchymal Chondrosarcoma

trial multicentrico 'Eribulin in Advanced Solitary Fibrous Tumor (ERASING)'

This is an Italian, non randomized, open label, multi center, investigator-initiated, Phase II, clinical study to explore the activity of eribulin in a population of patients with progressive, advanced (i.e. locally advanced or metastatic), molecularly proven SFT. Patients with a documented and centrally reviewed pathological diagnosis of locally advanced or metastatic SFT, and with an evidence of progression within the previous 6 months, may enter the study.

Study treatments will be administered till progression or toxicity. The primary end-point of the study is overall response rate Secondary end-points are Progression Free Survival (PFS), Overall Survival (OS) clinical benefit rate, response rate as by Choi criteria, duration of response.

Subjects already treated with one or two prior medical therapy regimens for the advanced phase, whatever agent used in first- or second-line, are eligible for inclusion in the study. Investigators will consider eligible for this study even patients naïve from chemotherapy, considering the limited activity of anthracycline in the disease.

Codice Clinical Trials: NCT03840772
Clinical Trials page: US ClinicalTrials.gov

First Posted : February 15, 2019

Centro coordinatore: Italian Sarcoma Group

Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS INT di Milano

Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD

Solitary Fibrous Tumor

 trial multicentrico 'A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)'

This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).

Codice Clinical Trials: NCT03673501
Clinical Trials page: US ClinicalTrials.gov

First Posted : September 17, 2018

Centro coordinatore: Deciphera Pharmaceuticals LLC

Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD

Gastrointestinal Stromal Tumors

trial multicentrico 'Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor (STRADA)'

Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or doxorubicin plus dacarbazine.

In case of progression or unacceptable toxicity while under the experimental treatment prior to the completion of the 6 cycles, the patients will be offered to cross to the other arm (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).

Codice Clinical Trials: NCT03023124
Clinical Trials page: US ClinicalTrials.gov

First Posted : January 18, 2017

Centro coordinatore: Fondazione IRCCS Istituto Nazionale dei Tumori

Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS INT di Milano

Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD

Solitary Fibrous Tumor