The Diagnosis of Chronic Pancreatitis

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Brief Title

The Diagnosis of Chronic Pancreatitis

Official Title

A Multimodal Approach to Diagnose Patients With Chronic Pancreatitis

Brief Summary

      To develop a new standardized multimodal diagnostic approach to CP considering:

      WP 1: Fat in faeces and functional testing; the combination of tests has to be easy to
      practice, should take as little time as possible and discomfort for the patient has to be
      minimized WP 2: Advanced ultrasonography and imaging modalities. The focus is on validating
      standard parenchymal, contrast enhanced and functional ultrasound compared to a modern
      imaging standard. (CT, EUS, MRI)

      To evaluate the reliability and feasibility of these novel methods in healthy volunteers; AND

      To compare findings in known severe CP patients and different stages of pancreatic
      insufficiency in patients with CP.
    

Detailed Description

      WP 1: Exocrine function testing

      Aims:

      Evaluating an endoscopic short test in patients with suspected pancreatic disease. Main focus
      on Chronic pancreatitis. (Collaborations to other patient groups in other protocols and to a
      group of healthy controls. )

      Methods:

      Secretintsimulated Endoscopic short test With duodenal sampling 30-45 minutes after secretin
      stimulation. Measurement of duodenal enzymes and duodenal bicarbonate concentration.

      Inclusion:

      Consecutive patients referred to a specialist outpatient clinic under suspicion of CP.

      End Points:

      Duodenal bicarbonate and enzyme concentrations. CP diagnosis by Layer/ Mayo score.
      Statistics: Simple comparishments of grpup means. Accuracy calculations by ROC curves.
      Sensitivity/ specificity calculations.

      Sample size: Power and number of patients at baseline are calculated based on the following
      assumptions: The smallest difference between the pancreatic sufficient and the insufficient
      groups rejecting the null hypothesis are estimated to 25% regarding peak bicarbonate in EST.
      The worst case standard deviation is chosen 25%. Sample sizes of 14 patients in each group
      are expected to give the desired power of at least 0.80. Sample size: At least 15 patients in
      each group.

      WP 2: Testing of Advanced ultrasound Methods

      Aims:

      Evaluate the diagnostic accuracy of transabdominal ultrasound (US) compared to CP diagnosis
      by Layer/ Mayo score, Endoscopic ultrasound (EUS), previous CT/ MRI examinations and exocrine
      pancreatic function.

      Sample size:

      Power and number of patients at baseline are calculated based on the following assumptions:
      The smallest difference between the pancreatic sufficient and the insufficient groups
      rejecting the null hypothesis are estimated to 35% regarding peak bicarbonate in traditional
      criteria counting. (average 4 criteria vs average 2 criteria) The worst case standard
      deviation is chosen 25%. Sample sizes of 14 patients in each group are expected to give the
      desired power of at least 0.80.

      Sample size for interobserver variation analysis: Calculated by the principles of A
      Cantor(1). Assuming a relative error of 30% (Due to earlier observed large interobserver
      variations in these studies) , a clinical relevant kappa of 0.50 the estimated sample size
      must be above 44. We intended to include at least 60 patients with both US and EUS. In this
      setting kappa values below 0.4 must be interpreted with caution.

      Hypothesis:

        -  US can demonstrate changes in CP

        -  US can diagnose CP with good accuracy.

        -  US can demonstrate minimal changes in CP

        -  US findings have good agreement compared to CP

        -  Changes by US correlate to severity by exocrine pancreatic function.

      Inclusion criteria: : Consecutive adult patients (<16 years) referred to a specialized
      outpatient clinic with suspected chronic pancreatitis (CP) due to presenting symptoms or
      classical CP characteristics based on previous diagnostic imaging.

      Exclusion criteria:

        -  Patients unable to give informed consent.

        -  Patients who had undergone extensive pancreatic surgery

      In protocol exclusions pre-analysis:

        -  Subjects who did not fulfil the protocol for an adequate Mayo score

        -  Subjects with insufficient US visualization of the pancreas due to obesity, repeatedly
           overlying bowel air or other factors.

      Methods:

        -  Collection of clinical data and previous CT/ MRI examinations from electrical patient
           journal. Nutritional screening with Height/ Weight/ BMI. Laboratory tests. Blood for DNA
           in Biobank,

        -  Exocrine function tests. Short endscopic secretintest/ Faecal Elastase

        -  Transabdominal Ultrasound: On inclusion and repeated 1-2 times within 3 months.
           Operators blinded to clinical data.

      Registration of Rosemont criteria. Contrast enhanced ultrasound (CEUS) by Sonovue.

      Endoscopic ultrasound: blinded to the results of the US. (Subjects offered conscious sedation
      with intravenous midazolam and pethidine or fentanyl hydrochloride during the test procedure)
      Pancreas Scan from head to tail. Parenchymal and ductal criteria registered.

      Trial chronology:

        1. In advance: Invited to participate. Written information in advance.

        2. 1. Visit: Signed written consent. Anamnesis and nutritional score.

           o Ultrasound and EST

        3. 2. Visit: Information of result.

           o Repeated ultrasound with registration of Rosemont criteria and CEUS

        4. 3. Visit: EUS with Rosemont score.

        5. 4. Visit: Follow up, Information of results. Plan further follow up and treatment.

        6. Post analysis: Layer/ Mayo score. Rosemont/ traditional score of US and EUS

      Endpoints:

      CP diagnosis by Layer/ Mayo score Imaging scores: Traditional criteria count and Rosemont
      weighted score. Exocrine function results Endocrine function results Nutritional status
      results.

      Statistical analysis:

      Comparisons between groups are made using student t-tests or Mann-Whitney U-test as
      appropriate.

      Accuracy data calculated from receiver operator curves (ROC). 5% level of statistical
      significance will be used. Interobserver variation for the separate criteria will be
      calculated as Cohens kappa.

      Reliability for the ordinal data will be calculated as intraclass correlation coefficients
      (ICCs) in a random, two-way analysis. Data analyzed according to absolute agreement.

      Agreement will be defined according to Landis and Koch: 0 = no agreement, 0 - 0.20 = slight
      agreement, 0.21 - 0.40 = fair agreement, 0.41 - 0.60 = moderate agreement, 0.61 - 0.80 =
      substantial agreement, and 0.81--1 = almost perfect agreement. A clinically relevant
      agreement usually requires a value >0.5.

      Inclusion period: Starting from des 2009.

      Reference List

      1. Cantor A. Sample-Size calculations for Cohens Kappa. Psychological Methods 1996;1:150-153.
    


Study Type

Observational


Primary Outcome

Development of pancreatic insufficiency

Secondary Outcome

 development of diabetes

Condition

Chronic Pancreatitis

Intervention

diagnostic test

Study Arms / Comparison Groups

 Patients
Description:  Patients with suspected Chronic Pancreatitis

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

Other

Estimated Enrollment

100

Start Date

August 2009

Completion Date

August 2020

Primary Completion Date

August 2020

Eligibility Criteria

        Inclusion Criteria:

          -  The patients will be included from the Department of Medicine at Haukeland University
             Hospital in Norway. The Marseille-Rome diagnostic criteria will be used. Patients will
             be scored according to the Layer score. The symptoms should be unrelated to other
             systemic diseases.

        Exclusion Criteria:

          -  Personality disturbances and alcohol consumption 24 hours prior to the study. Any
             other diseases and drugs associated with malabsorption; pregnancy or lactating women;
             heart disease or allergy against MR or ultrasound contrast agents.
      

Gender

All

Ages

16 Years - 90 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Georg Dimcevski, PhD, 55972903, [email protected]

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT01059669

Organization ID

REK nr 241.08


Responsible Party

Principal Investigator

Study Sponsor

Haukeland University Hospital

Collaborators

 University of Bergen

Study Sponsor

Georg Dimcevski, PhD, Principal Investigator, Haukeland University Hospital


Verification Date

August 2016