View clinical trials related to Pancreatic Disease.
Filter by:The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.
Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. The perioperative artificial nutrition has for objectives to correct the preoperative malnutrition, and to maintain the nutritional status in the post-operative period. The current guidelines in surgery are in favour of a realisation of a perioperative artificial nutrition support that privilege the enteral nutrition. However, after pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the early postoperative period, although rare studies suggest a benefit of the enteral nutrition in term of reduction of the post-operative complications. Indeed, no recommendation was formulated concerning early enteral nutrition after pancreaticoduodenectomy because few studies were realized on its profits. The data of the literature report rates of complications (essentially major) from 49 % to 59 % after major digestive surgery (not only pancreatic) on patients having received a total parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early enteral nutrition. A preliminary prospective study realized in the investigators centre showed a rate of 74 % complication versus 44 %, respectively in the total parenteral nutrition and early enteral nutrition groups (50 patients in every group, with p < 0.01. All the complications were listed prospectively). Hypothesis : The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 % versus 40 %).
Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This intervention is associated with a high rate of postoperative complications including: - pancreatic fistulas (PF); - surgical site infections (intra-abdominal abscess, wound infection); - delayed gastric emptying (gastroparesis); - and hemorrhage. The incidence of SSI (superficial and deep) is about 35% and seems influenced by the prolonged intra-abdominal drainage. For several years, there has been a global trend to reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical trials have shown that prophylactic drainage does not decrease the incidence of postoperative complications during elective hepatectomy, colectomy, and cholecystectomy and could increase the number of SSI. However, the role of prophylactic drainage after PD is so far unclear. The aim of this prospective randomized multicenter study is to evaluate the influence of early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice) drainage removal of the abdominal cavity after PD, on the rate of SSI. Materials and Methods: The technique of PD is left at the discretion of the operator as well as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of one or two round silicone close suction drains or open multichannel silicone drains placed in the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In case of pancreatic fistula, the patient is excluded from randomization and drainage of the abdominal cavity is left in place depending on the different teams' practice. Patients without fistula are randomized to either drainage removal 4 days after surgery (D4) or standard drainage.
The following are the study hypothesis: - Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates. - Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.
A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.
RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future. PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.
Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1 mmol/l' level for blood glucose control in ICUs according to two large randomized control trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In this study, the investigators would like to evaluate that the target of blood glucose level, whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for the reduction of perioperative mortality and complications.
Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients <= 2 years of age. The results of this study are intended to be submitted to the FDA as part of the NDA package for marketing approval of PANCRECARB (DCI 1020).