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Pancreatitis, Chronic clinical trials

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NCT ID: NCT00651053 Completed - Clinical trials for Chronic Pancreatitis

Endoscopic Ultrasound Compared With Pancreatic Function Testing for Diagnosis of Chronic Pancreatitis

Start date: May 2005
Phase: N/A
Study type: Interventional

This is a investigator-initiated, single-center, prospective study to evaluate endoscopic ultrasound (EUS) as a diagnostic test for chronic pancreatitis (CP). EUS detects abnormalities of the pancreas that may represent scarring from CP. The validation of any new test requires a comparison with the best available reference standards. There is no true "gold standard" for diagnosis of CP; however, pancreatic function testing (PFT) is highly sensitive for exocrine dysfunction as a surrogate for early fibrosis, and is widely considered the non-histologic gold standard. There are no well-designed prospective studies comparing EUS with PFT as reference standard. EUS detects parenchymal and ductal features of CP said to correlate with fibrosis. We hypothesize that a predominance of parenchymal fibrosis results in diminished acinar-cell secretion of enzymes. Conversely, a predominance of ductal fibrosis results in impairment of ductal secretion of bicarbonate. Because secretin and cholecystokinin (CCK) PFTs measure unique aspects of pancreatic function (duct-cell and acinar-cell function, respectively), the use of both hormonal stimulants will allow the most comprehensive investigation of the significance of EUS features. There are no studies comparing EUS with combined or dual performance of secretin and CCK PFTs. The primary objective of this study is to determine the test characteristics of EUS for diagnosis of CP compared with dual secretin- and CCK- stimulated PFTs as reference standard. Secondary objectives include to: 1. Determine the optimal number and relative functional importance of specific EUS criteria, 2. Compare the test characteristics of linear- and radial-array EUS. 190 patients evaluated for pancreatitis or pancreatic-type abdominal pain will undergo the "new test" (radial and linear EUS) and the reference standard (CCK and secretin PFTs). The EUS examinations will be videotaped and interpreted in a blinded fashion. EUS scores will be compared with PFT results to allow the calculation of sensitivity and specificity of linear and radial EUS. Receiver operating characteristics (ROC) analysis will be used to determine the optimal number of EUS criteria for diagnosis.

NCT ID: NCT00638573 Completed - Clinical trials for Type 2 Diabetes Mellitus

The Incretin Effect in Patients With Chronic Pancreatitis

Start date: January 2006
Phase: N/A
Study type: Observational

The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a primary event leading to T2DM or if it is merely a consequence of the diabetic state. To answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.

NCT ID: NCT00630279 Terminated - Clinical trials for Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Start date: February 2008
Phase: Phase 2
Study type: Interventional

This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency

NCT ID: NCT00621283 Terminated - Clinical trials for Chronic Pancreatitis

Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

Start date: February 2008
Phase: Phase 1
Study type: Interventional

1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography. 2. To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic pancreatitis. 3. To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the pancreatic duct as compared to the non-enhanced MRCP. 4. To assess pancreatic exocrine function by quantifying pancreatic fluid output into the duodenum and the apparent diffusion coefficient of the pancreas.

NCT ID: NCT00620919 Terminated - Clinical trials for Chronic Pancreatitis

Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis

Start date: February 2008
Phase: Phase 1
Study type: Interventional

1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Multidetector Computed Tomography (MDCT) of the pancreas. 2. To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in patients with chronic pancreatitis. 3. To evaluate if RG1068 enhanced MDCT results in improved delineation of structural abnormalities of the pancreatic duct as compared to non-enhanced MDCT.

NCT ID: NCT00588367 Completed - Clinical trials for Pancreatic Ductal Adenocarcinoma

CT Pancreas Perfusion

Start date: April 2006
Phase: N/A
Study type: Observational

1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis. 2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use). 3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.

NCT ID: NCT00583479 Completed - Pancreatic Cancer Clinical Trials

Prospective Study of Celiac Block Injection: 1 vs. 2

Start date: June 2002
Phase: Phase 4
Study type: Interventional

The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.

NCT ID: NCT00583271 Completed - Pancreatic Cancer Clinical Trials

A Prospective Study of EUS Guided Celiac Block

Start date: June 2002
Phase: N/A
Study type: Observational

The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.

NCT ID: NCT00559364 Completed - Clinical trials for Chronic Pancreatitis

Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

Start date: November 2007
Phase: Phase 3
Study type: Interventional

This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly Axcan).

NCT ID: NCT00500084 Terminated - Clinical trials for Exocrine Pancreatic Insufficiency

Phase III ALTU-135 CP Safety Trial

DIGEST CP
Start date: December 2007
Phase: Phase 3
Study type: Interventional

This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).