Clinical Research Directory

PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies

Esophageal cancer ranks as the seventh leading cause of cancer globally, with 604,100 new cases, and the sixth leading cause of cancer-related deaths worldwide. When applicable, surgery is the gold standard treatment for resectable oesophageal-esophagogastric junction cancer. The surgical technique requires both an abdominal approach and a transthoracic approach to resect the esophagus, perform the anastomosis, and allow optimal lymph node removal. Surgery Historically, esophagectomy was performed entirely through open surgery. This procedure was complex, associated with significant morbidity and mortality, as well as intense acute and chronic postoperative pain. In this context, thoracic epidural analgesia (TEA) is the gold standard in the management of acute postoperative pain. It allows for opioid sparing and reduces postoperative pulmonary complications. In order to reduce postoperative pain, facilitate postoperative recovery and limit postoperative complications, particularly respiratory complications, the minimally invasive approach has been proposed for several surgical indications. This principle has led to the development of hybrid esophagectomy, i.e. an abdominal approach by laparoscopy and a thoracic approach by right thoracotomy. An abdominal laparoscopic approach during esophagectomy, even in combination with a right thoracotomy, would therefore limit postoperative complications compared to open surgery. In parallel to the wider use of hybrid esophagectomy, some teams have demonstrated the feasibility of a totally minimally invasive esophagectomy (TMIE), first video-assisted, then robot-assisted. The rise of minimally invasive surgery (both hybrid and totally minimally invasive) has led to a decrease in postoperative pain compared to open surgery. Enhanced recovery after surgery protocols have been developed to improve postoperative recovery and management of acute postoperative pain. In this context, thoracic epidural analgesia TEA may prove counterproductive by inducing arterial hypotension requiring vasopressor drugs, acute urinary retention, and limiting mobilization. Moreover, thoracic epidural analgesia TEA failure occurs in 30% of cases. In minimally invasive surgery, it may be inadequate in half of the patients. Paravertebral block (PVB) appears as a satisfactory alternative for postoperative analgesia management. In this sense, PVB is recommended for pain management in thoracoscopic lung. Evidence of the effectiveness and interest of the paravertebral catheter is lacking regarding totally minimally invasive esophageal surgery as most studies demonstrating the benefit of Paravertebral block PVB in esophageal surgery were retrospective.

Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.

Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA)

PANACOTTA is a multicenter randomized controlled trial including patients with symptomatic chronic pancreatitis and a dilated main pancreatic duct to either robot-assisted or open lateral pancreaticojejunostomy. The PANACOTTA trial will assess the post-operative quality of recovery following robot-assisted versus open lateral pancreaticojejunostomy.

ERAS Program Implementation for MIPD

To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)

The TriggerHappy Trial

This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)

Even after the wide introduction of chemo/radiotherapy in the treatment algorithm, adequate surgery remains the cornerstone of gastric cancer treatment with curative intent. A proper D2 lymphadenectomy is associated with improved cancer specific survival as confirmed in Western countries by fifteen-year follow-up results of Dutch and Italian randomized trials. In clinical practice, the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy; nonetheless, the number of retrieved nodes does not necessarily correlate with residual nodes, which intuitively could represent a more reliable marker of surgical adequacy. The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes. The goal of this multicentric observational prospective study is to test the reliability of a new score (PhotoNodes Score) created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer. The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopic/robotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection. Ideally, this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer.

Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy

This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. The primary objectives include investigating: Question 1: The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy. Question 2: The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction, mid-left ventricular obstruction, and in individuals with or without organic valvular lesions. Question 3: The effects of the two surgical procedures on exercise capacity, quality of life, and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction, both with and without valvular lesions. Participants will be stratified into two groups. The experimental group will undergo thoracoscopic Morrow surgery, while the control group will undergo median open modified enlarged Morrow surgery.

Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.

Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)

The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.