Pancreatic Perfusion Using Secretin and MRI

Learn more about:
Related Clinical Trial
Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis Prospective Registry Of Therapeutic EndoscopiC ulTrasound Intermittent Fasting for Pancreatitis Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies, the PROCEED Study Relationship of CP and AP Personalized Education and Pain Response in Chronic Pancreatitis A Prospective Cohort Study of Large Pancreatic Radiolucent Stone Risk Factors for Post-ESWL and Post-ERCP Pancreatitis Intraductal Liposomal Bupivacaine for Chronic Pancreatitis An Observational Study on the Natural Course of Chronic Pancreatitis Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study Malnutrition in Chronic Pancreatitis, Trans-sectoral Study Project Survival-Prospective Biomarker Discovery Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study Volatiles in Breath and Headspace Analysis – Diagnostic Markers Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis Cancer in Patients With Gabapentin (GPRD) A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma Rectal Indomethacin to Prevent Post ESWL-pancreatitis T-EUS for Gastrointestinal Disorders: A Multicenter Registry Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool Contrast EUS of the Pancreas Idiopathic Recurrent Acute Pancreatitis (IRAP) Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study) Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis Endoscopic Ultrasound (EUS) Processor Comparison The North American Pancreatitis Study A Prospective Observational Study of TPIAT Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation Economisation of Whipple Resection Using an Ultrasonic Dissection Device Biospecimens for Identification of Diseases of the Pancreas. Diagnosis of Bile Duct Strictures Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD) Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT Prospective Study of Celiac Block Injection: 1 vs. 2 Online Health Assessment to Support Comprehensive Care Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population Role of CXCR2 Ligands/CXCR2 Biological Axis in Pancreatic Cancer Mesenchymal Stem Cell and Islet Co-transplantation Analysis of Graft Function Following Autologous Islet Transplantation Carbon Monoxide-Saturated Medium for Islet Isolation Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) in Focal Pancreatic Masses Endoscopic Ultrasound Elastography in Pancreatic Masses Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis A Prospective Study of Natural History of Pancreatitis Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain ESWL Versus ESWL and Endoscopic Treatment SpHincterotomy for Acute Recurrent Pancreatitis A Prospective Study of EUS Guided Celiac Block A Dose Ranging Study Evaluating Efficacy and Safety of NI-03 Examining Macrophage Influx and Vascularization in Chronic Pancreatitis Enzyme Suppletion in Exocrine Pancreatic Dysfunction ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis A Phase IIa Study With Escalating Dose of MS1819-SD Decrease of Recurrent Pancreatitis Celiac Plexus Block for Chronic Pancreatitis RCT Pancreatic Perfusion Using Secretin and MRI Viokase 16, Viokase16 Plus Nexium and Nexium Alone Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis Endoscopic Stenting for Chronic Abdominal Pain WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) The Incretin Effect in Patients With Chronic Pancreatitis Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis Fibro-inflammatory Progression From Acute to Chronic Pancreatitis CT Pancreas Perfusion CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption The Natural History of Chronic Pancreatitis BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency Is There an Association Between Chronic Pancreatitis and Pulmonary Function Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis Endoscopic Ultrasound Compared With Pancreatic Function Testing for Diagnosis of Chronic Pancreatitis A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing Pain and Chronic Pancreatitis – Clinical End Experimental Studies A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis Trial of Indomethacin in Chronic Pancreatitis The Diagnosis of Chronic Pancreatitis Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality Effect of Acetyl-L-carnitine on Chronic Pancreatitis Establishing Standards for Normal Pancreatic EUS The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis Secretin Infusion for Pain Due to Chronic Pancreatitis Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis Elastography in the Diagnosis of Chronic Pancreatitis The PASTEC Study: Endoscopic Stenting Versus Surgery for the Treatment of Bile Duct Stricture in Chronic Pancreatitis Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies Endoscopic Versus Surgical Treatment of Chronic Pancreatitis Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis Novel Breath Test to Detect Early Stage Chronic Pancreatitis Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions Dietary Soy Isoflavones In Chronic Pancreatitis Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis Nerve Growth Factor in Chronic Pancreatitis Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT) Role of Antioxidants Supplementation in Chronic Pancreatitis Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis Bone Disease in Chronic Pancreatitis: A Complex Phenomenon Correlation of Chronic Pancreatitis Pathology Features With Endoscopic Ultrasound (EUS) Criteria

Brief Title

Pancreatic Perfusion Using Secretin and MRI

Official Title

Study to Assess Pancreatic Blood Flow at Rest and During Stimulation Using Magnetic Resonance Imaging (fMRI) in Patients With Chronic Pancreatitis

Brief Summary

      The purpose of this study is to assess pancreatic perfusion in patients with chronic
      pancreatitis at rest and after secretin stimulation and compare this to published data on
      pancreatic perfusion in normal subjects.
    

Detailed Description

      Pancreatic blood flow or perfusion is difficult to quantify due to the complex vascular
      supply to the organ and its retroperitoneal location, adjacent to the abdominal aorta. The
      pancreas is supplied by the superior gastroduodenal artery from the celiac plexus, branches
      from the hepatic and splenic arteries, which originate from the celiac plexus, and the
      inferior gastroduodenal artery, which originates from the superior mesenteric artery.
      Identifying changes in flow in all these vessels with good spatial and temporal resolution is
      challenging but important in understanding many of the chronic conditions of the pancreas.

      Chronic pancreatitis (CP) is an inflammatory condition of the pancreas leading to
      irreversible damage to the tissue. It is increasing in incidence in all nations, and is
      related to rising alcohol consumption and improved diagnostic techniques. In Europe the
      incidence is approximately 6-7/100,000 population. 73-91% of patients affected are male with
      an average age of 49-60yrs. Patients affected by CP have a high morbidity, such as diabetes
      and chronic abdominal and/or post-prandial pain in 80-90%, which required frequent hospital
      admission, control-drug prescriptions and intervention by specialist hospital services.
      However the mechanisms of chronic and post-prandial pain for CP patients are not well
      understood, but tissue ischaemia, inflammation and neurological changes have been proposed.
      These mechanisms may be inter-related with pancreatic inflammation and neurochemical changes,
      such as an increase substance P, which can produce vasoconstriction, reducing pancreatic
      perfusion and worsening ischaemia of intra-pancreatic nerves(3). A greater understanding of
      the ischaemic and inflammatory mechanisms behind the pain in CP, would greatly enhance the
      development of treatment for this and other debilitating conditions.

      There are a few studies of pancreatic tissue perfusion in humans, those studies which have
      assessed perfusion have used invasive techniques such as endoscopic or laparoscopic
      measurement and hydrogen gas clearance methods. Although these methods have demonstrated
      decreased resting blood flow and little response to secretin stimulation in CP patients
      compared to healthy controls, the techniques are highly invasive, time consuming and
      expensive and can cause the participant significant morbidity. This has led to several
      non-invasive techniques including infusion of oxygen-15 water and positron emission
      tomography (PET), contrast-material-enhanced trans-abdominal ultrasound (US) or
      contrast-enhanced dynamic computer tomography (CT). However these techniques involve infusion
      of an exogenous marker to detect the change in flow rate and often require a radiation
      exposure or are operator dependant and give poor spatial or temporal resolution, limiting the
      usefulness of the studies.

      MRI is an attractive alternative for the assessment of pancreatic perfusion, providing good
      spatial and temporal resolution with no radiation exposure. Two methods can be used,
      Contrast-Enhanced (CE) MRI or Arterial Spin Labelling (ASL) techniques. ASL provides a tool
      for quantitative assessment of tissue perfusion without the need for contrast administration.

      Contrast-enhanced MRI using gadodiamide has been used to explore the changes in pancreatic
      perfusion with secretin stimulation. This study in 10 healthy volunteers demonstrated that at
      rest there was a higher blood flow within the body and the tail of the pancreas, compared to
      the head. With secretin stimulation there was a significant increased perfusion in all
      regions of the pancreas. ASL techniques, do not require exogenous contrast agents, only two
      previous studies have measured pancreatic perfusion with ASL, one exploring pancreatic
      exocrine functions in type 1 diabetics. A recent study at the Nottingham Digestive Diseases
      Centre on pancreatic perfusion measurement using ASL at baseline and after intravenous
      secretin stimulation has standardised the MRI technique of measuring pancreatic perfusion.

      There are no studies using MRI ASL to measure pancreatic perfusion in patients with chronic
      pancreatitis after secretin stimulation. This pilot study aims to test the feasibility of
      using MRI ASL to measure pancreatic perfusion in patients with chronic pancreatitis with a
      view to perfecting the technique. This will allow future studies comparing pancreatic
      perfusion in healthy adult controls to patients with chronic pancreatitis thus improving the
      investigators understanding of the pathophysiology of pain in patients with chronic
      pancreatitis.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Blood flow to pancreas as measured by arterial spin labelling MRI

Secondary Outcome

 Change in blood flow to pancreas after intravenous secretin

Condition

Chronic Pancreatitis

Intervention

Secretin

Study Arms / Comparison Groups

 Secretin
Description:  Secretin 1 IU/kg over 3 min

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

June 2012

Completion Date

June 2016

Primary Completion Date

April 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Adults with chronic pancreatitis (as defined by the Cambridge criteria)

        Exclusion Criteria:

          1. Allergy to secretin

          2. Claustraphobia

          3. Refusal to consent for the study

          4. MRI contraindications e.g. pacemaker, artificial heart valve

          5. Previous abdominal surgery except appendectomy or hernia repair

          6. History of chronic abdominal pain from causes other than pancreatitis eg. inflammatory
             bowel or coeliac disease

          7. Pregnant women (safety concerns from injection of secretin)

          8. Patients younger than 18 years of age
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

John Simpson, , [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02458118

Organization ID

11109


Responsible Party

Sponsor

Study Sponsor

University of Nottingham


Study Sponsor

John Simpson, Principal Investigator, University of Nottingham


Verification Date

February 2016