View clinical trials related to Pancreaticoduodenectomy.
Filter by:The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.
Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary and pancreatic diseases including malignant and benign conditions. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care. Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited. In this prospective randomized study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD compared to conventional open PD.
The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay. The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.
Up to now, the studies concerning nutritional assessment after pancreatic resection were rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant benefit in terms of nutritional status. This study is a multicenter randomized phase IV study by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status after pancreaticoduodenectomy.
Pancreatic resection is the only potentially curative modality of treatment for pancreatic neoplasm. The mortality associated with this procedure decreased rapidly in the past decades. However, the morbidity associated with pancreatic resection remains high. The main reason for postoperative morbidity is postoperative pancreatic fistula (POPF), which is regarded as the most ominous complication following pancreatic resection. Its reported incidence varies in the surgical literature from 10% to >30%. Recently published studies showed that the placement of intraoperative drains, manipulation with the drains, timing of removal of the drain, and especially the type of drain, have significant effect on the postoperative complications, and especially POPF. Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two most commonly used systems are closed suction drainage and closed gravity drainage. Open systems have been abandoned in most centers as they are obsolete. Our hypothesis is that the closed suction drain will have better results as it is more effective than the gravity drainage. However, some surgeons claim that the suction system can actively suck the pancreatic juice through the anastomosis or suture and thus promote the development of POPF. The aim of this study is to compare closed suction drains and closed gravity drains after pancreatic resection in a randomized controlled study. The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point is the postoperative morbidity.
Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups
From postoperative patients having undergone pancreaticoduodenectomy; 1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven 2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient 3. To compare the safety of the 2 intravenous colloids in the patient population
Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.
The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.