Clinical Research Directory

Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia

This randomized clinical trial compares the hemodynamic effects of general anesthesia versus combined general anesthesia (thoracic epidural) in patients undergoing pancreatoduodenectomy. The primary aim is to assess the incidence of intraoperative hypotension and related adverse events. Secondary outcomes includes vasopressor requirements, transfusion needs, postoperative complications, intensive care unit admission, hospital length of stay, and mortality.

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy. The main questions are: Does nefopam administration reduce opioid consumption after pancreatoduodenectomy? Does nefopam administration reduce postoperative pain levels after pancreatoduodenectomy? Researchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes. Participants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.

PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)

This is a prospective, randomized, double-blind, single-center clinical trial designed to evaluate the effects of Clostridium butyricum CBM588 supplementation on postoperative diarrhea, gastrointestinal symptoms, and quality of life in patients undergoing pancreaticoduodenectomy for periampullary neoplasms. Oncological outcomes, including disease-free survival and overall survival, will be monitored as secondary endpoints during follow-up.

Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

The purpose of this study is to determine if the use of antiseptic-coated sutures is better than the use of the standard sutures in preventing postoperative fistulas within 90 days after pancreatoduodenectomy.

Characteristics of Intestinal Microbiome Following Pancreatic Surgery

The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls. The primary objectives of the study are: 1. To explore and describe any differences in the gut microbiota especially Shannon diversity index 2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls. Participants will be asked to complete the following: * Three-day food, bowel and medication diary (see Protocol appendix 5) * Gastrointestinal Symptom Rating Scale (see Protocol appendix 6) * Quality of life questionnaire (see Protocol appendix 7) * Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory)

Duration of Perioperative Antibiotics in Pancreatoduodenectomy

The goal of this clinical trial is to learn if different prophylactic antibiotic regimens can prevent surgical site infections in adult patients undergoing pancreatoduodenectomy. The main questions it aims to answer are: Does a single preoperative dose of cefazolin reduce the risk of surgical site infection? Does a three-day combination of cefotaxime plus metronidazole reduce the risk of surgical site infection? Researchers will compare a single dose of cefazolin to a three-day course of cefotaxime + metronidazole to see if there is a difference in postoperative infection rates. Participants will: * Be randomly assigned to one of two antibiotic regimens before and after surgery * Receive either Arm A: one dose of cefazolin immediately before surgery Arm B: cefoxitin for perioperative antibiotics followed by cefotaxime plus metronidazole administered for three days after surgery * Undergo routine postoperative monitoring for signs of infection * Have any surgical site infections and related complications recorded until 30 days after surgery

Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy

The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF). Patients undergoing PD will be randomized into two arms: * arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis * arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis The rate of occurrence of CR-POPF will be compared between the two arms.

A Multicenter Prospective Observational Study of Computer-aided Risk Perception and Prognosis Prediction in the Whole Process of Laparoscopic Hepatobiliary and Pancreatic Surgery

Artificial intelligence technology is used to realize high-quality 3D scene reconstruction, whole process segmentation, scene activity understanding for common surgery guidance in hepatobiliary surgery, as well as intelligent identification, perception, early warning of key events in the whole process of endoscopic surgery (such as bleeding, blocking, tumor location, anastomosis, etc.), and decision-making assistance

METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy

Pancreatoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology. The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications. Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).

Mesopancreas Study in Pancreatic Cancer

After the Introduction of the pathological circumferential resection margin (CRM status by LEEPP Protocol), residual cancer (R1 resection) was most often found in the dorsal and medial resection margins. Yet only the medial resection margin is preoperatively evaluated during staging, while the dorsal resection margin which embeds the mesopancreatic fat and thus resembles the area of the mesopancreas, is not considered during preoperative assessment for resectability. Local recurrence is similarly prevalent as systemic relapse, and revised lower rates of R0CRM- resections through the LEEPP protocol explained the poor local tumor control. The aim of this study is to interdisciplinary approach the circumferential infiltration status of the PDAC concentrating foremost on the mesopancreas of the dorsal resection margin by including anatomic and embryologic derived perspectives.