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Pancreatic Diseases clinical trials

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NCT ID: NCT03578770 Completed - Pancreatic Diseases Clinical Trials

Safety and Efficacy of the New 20 mm Lumen Apposing Metal Stent (Lams) for Endoscopic Treatment of Pancreatic and Peripancreatic Fluid Collections

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Pancreatic fluid collections (PFC) can occur as a complication of acute and chronic pancreatitis. PFC include pancreatic pseudocysts (PP) and walled-off necrosis (WON). The majorities of WON are asymptomatic and will resolve spontaneously. Endoscopic ultrasound (EUS)-guided drainage has become the preferred treatment in the management of symptomatic PFC, with significant advantages compared with surgical and percutaneous drainage. Successful endoscopic management of the pancreatic fluid collections depends on the type of PFC. Studies have shown that endoscopic drainage of PP is greater than 90%, while success for WON is at best between 50-65%. Differences in treatment outcome are attributed to the viscosity and debris content of the PFC. Traditionally, the EUS-guided drainage has been performed with placement of multiple plastic stents or fully covered self-expanding metal stent. Recently, lumen-apposing metal stents (LAMS) have been developed. LAMS have been utilized for the access and drainage of pancreatic fluid collections (PFCs). To date, a variety of LAMS sizes have been commercially available and widely used. Studies have shown high technical success (89-100%) and high clinical success rate (93-100%). The larger diameter of LAMS facilitates better drainage of PFC contents when compared to the small caliber of plastic stents and allows necrosectomy in repeated sessions without the need for stent replacement. A new LAMS with a larger (20mm) lumen diameter (the Hot Axios, Boston Scientific, Natick MA, USA) was released on the market, with the idea that a larger diameter would allow a faster drainage of PFCs and facilitate endoscopic necrosectomy. This is currently the largest diameter LAMS available. Further studies are needed to determine the ideal size for a LAMS going forward to achieve maximal clinical benefit with minimal patient risk. Aim of the investigator's study is to evaluate the safety and efficacy of the new 20 mm Hot Axios stent placement for EUS-guided transmural drainage of pancreatic fluid collections.

NCT ID: NCT03535727 Completed - Neoplasms Clinical Trials

A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer

Start date: June 21, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.

NCT ID: NCT03410914 Completed - Surgery Clinical Trials

Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy

PATCH-DP
Start date: August 13, 2018
Phase: Phase 2
Study type: Interventional

Despite improvements and advances in pancreas surgery, about 30-35% of patients who have pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term consequences.We are studying the effect of a medical device named HEMOPATCH on the development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine protein-based pad that may improve tissue sealing where it is applied during surgery. Some small studies called case studies of between 2 and 7 patients, and two clinical trials have shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some types of surgery. However, there have been no completed clinical trials using HEMOPATCH to prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or leakage of other body fluids or air by standard surgical techniques are either ineffective or impractical.

NCT ID: NCT03394378 Completed - Acute Pancreatitis Clinical Trials

The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis

Start date: November 6, 2017
Phase: N/A
Study type: Observational

Obesity is a well-established risk factor for acute pancreatitis (AP). As for non-alcoholic fatty pancreas disease (NAFPD), it is evident that it is correlated with obesity. This is apparently the first study evaluating the association between NAFPD and severity of AP after taking into account several covariates.

NCT ID: NCT03303196 Completed - Diabetes Clinical Trials

Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes

Start date: April 9, 2018
Phase: N/A
Study type: Interventional

This is a pilot study designed to determine if the bihormonal bionic pancreas provides improved blood glucose control, compared to the current standard of care, in individuals with hyperinsulinism who developed diabetes after having a pancreatectomy.

NCT ID: NCT03198871 Completed - Pancreatic Diseases Clinical Trials

IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population

Start date: May 24, 2018
Phase: Phase 4
Study type: Interventional

Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).

NCT ID: NCT03169998 Completed - Liver Diseases Clinical Trials

Effect of Goal-directed Fluid Therapy on Postoperative Complications

Start date: January 1, 2017
Phase:
Study type: Observational

- It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods. - Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far. - To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods

NCT ID: NCT02971579 Completed - Pancreatic Diseases Clinical Trials

A Register on the Quality of ERCP and Training of Endoscopists in Italy

REQUEST
Start date: September 2016
Phase:
Study type: Observational

This is a prospective observational longitudinal study Aim of the study is to collect information: - on the organization models of the Endoscopic Units performing ERCP in Italy - on the previous and/or ongoing training of the endoscopists performing ERCP - on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome

NCT ID: NCT02916199 Completed - Pancreatic Diseases Clinical Trials

Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

Start date: October 4, 2016
Phase: N/A
Study type: Interventional

The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods.

NCT ID: NCT02739074 Completed - Pancreatic Diseases Clinical Trials

Effectiveness of Metal Protheses Covered in "Diabolo" in Treatment of Necrosis of Origin Pancreatic: Trial "DIABOLOPIG"

DIABOLOPIG
Start date: March 25, 2016
Phase:
Study type: Observational

Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal or gastric) has become a standard technique validated. The rate of high technical and clinical success (76 to 91% in 3 months) and the lower morbidity in the literature explains that validation. However this treatment is done at the cost of a higher median number of treatment sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and potentially high costs. The constant improvement of therapeutic endoscopy equipment was allowed to see the advent of metal prosthesis completely covered by a membrane allowing them endoscopic extraction with ease. It has thus been recently developed short prostheses, of large diameter (up to 15/16 mm), with broad flange (or stent "diabolo") to be considered for use in the drainage of digestive peri collections. Few studies respectively determined the effectiveness of this type of prosthesis in the drainage of peri digestive collections Under echo endoscopy and treatment of necrosis of pancreatic origin. The purpose of this work is to evaluate multicenter prospective clinical and technical efficiency of laying completely covered stent "diabolo" in echo endoscopy for the treatment of necrosis of pancreatic origin.