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EUS Ductal Evaluation in One Endoscopic Session for the Diagnosis of Exocrine Pancreas Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01997476
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
John DeWitt, Indiana University

Brief Summary:

The purpose of this study is, to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate endoscopic sessions). The desired outcome is to diagnose CP and to establish an acceptable protocol for performing this combined technique. It is expected that combining these procedures will eliminate redundant portions of the procedures, reduce repeat visits to the hospital, reduce total recovery time for the patient, and will decrease the associated costs of separate procedures. Chronic pancreatitis (CP) is an irreversible, disease in which the pancreas becomes fibrotic ( thickened and scarred). Symptoms almost always include pain, and as the pancreas becomes progressively more fibrosed (thickened), pancreatic hormonal function is compromised with diarrhea and weight loss. However, while most physicians can readily diagnose patients with severe CP, early CP or "minimal-change" CP is difficult to detect, often due to the lack of radiologic findings, laboratory tests and classic symptoms. As a result, clinicians are searching for diagnostic tools which will allow for earlier, accurate detection of this disease, with the hope that appropriate therapy can be initiated before extensive thickening and scarring of the pancreas occurs.

Diagnostic tools to evaluate the pancreas include Endoscopic Ultrasound (EUS), hormone-stimulated endoscopic pancreatic function tests (ePFT) and Secretin stimulated Endoscopic Pancreas Function Test (sPFT) using pancreatic fluid (containing bicarbonate) obtained from the duodenum (the part of the intestine where the stomach opens into the small bowel). EUS is increasingly being used as a diagnostic and treatment tool in pancreatic disease. Currently, hormone-stimulated ePFT is considered the best way to diagnose chronic pancreatitis (long-lasting inflammation and scarring of the pancreas), and removes the need for biopsy or surgery. It is also sensitive in detecting mild disease.

These procedures are standard of care (the normal care you would receive) for the evaluation of CP. The purpose of this study, is to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session, instead of three separate endoscopic procedures.


Condition or disease Intervention/treatment Phase
Pancreatic Disease Procedure: Combined EUS, e-PFT and sEUS Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Combined Endoscopic Ultrasound Ductal Evaluation Before & After Secretin Stimulation in One EUS Session for the Diagnosis of Exocrine Pancreas Disease
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : February 6, 2018
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined EUS, e-PFT and sEUS Testing

Establish the advantage of combined EUS, ePFT & sEUS testing to provide a more definitive diagnostic assessment, rather than each test alone.

Establish the advantage of reduced time and cost of combining EUS and ePFT, rather than when done separately.

Procedure: Combined EUS, e-PFT and sEUS Testing

advantage of combined EUS, ePFT & sEUS testing to provide a more definitive diagnostic assessment, rather than each test alone.

Establish the advantage of reduced time and cost of combining EUS and ePFT, rather than when done separately.





Primary Outcome Measures :
  1. Combined Endoscopic Ultrasound Morphologic Evaluation, Endoscopic Pancreatic Function Testing (ePFT), and Dynamic EUS Ductal Evaluation (sEUS) [ Time Frame: 48 months (anticipated) ]
    Combined Endoscopic Ultrasound Morphologic Evaluation, Endoscopic Pancreatic Function Testing, and Dynamic EUS Ductal Evaluation before and after Human Secretin Stimulation in one Endoscopic Session for the Diagnosis of Exocrine Pancreas Disease


Secondary Outcome Measures :
  1. Advantage of combining EUS and ePFT to provide a more definitive diagnostic assessment, rather than each test alone. [ Time Frame: 48 months (anticipated). ]

    Establish the advantage of combining EUS and ePFT to provide a more definitive diagnostic assessment, rather than each test alone.

    Establish the advantage of reduced time and cost of combining EUS and ePFT, rather than when done separately.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female, between the ages of 18-80 years old.
  2. Clinical suspicion of pancreatic exocrine disease.
  3. If female and not more than 1 year post-menopausal or surgically sterile, must use medically acceptable form of contraception or abstain from sexual activity during the study. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Screening Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
  4. EUS and ePFT planned for structural and functional evaluation of the exocrine pancreas.
  5. Ability to undergo conscious sedation or monitored anesthesia.
  6. Willing and able to sign written informed consent.

Exclusion Criteria:

  1. Symptoms of acute pancreatitis within 30 days of the combined function test.
  2. Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
  3. Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
  4. Severe renal disease (history of acute or chronic renal failure and/or dialysis dependent and/or baseline creatinine >2.0 mg/dL).
  5. Pregnant or nursing.
  6. Ongoing illicit drug use or abuse.
  7. Ongoing moderate or severe alcohol use defined by greater than 30 grams alcohol/day.
  8. Acute pancreatitis as defined by the Atlanta Classification definition (see Appendix D) within the previous two months.
  9. Prior pancreatic surgery.
  10. Presence of a condition which may interfere with exocrine pancreatic functioning including celiac disease, type I diabetes mellitus, previous gastrectomy, cystic fibrosis or severe malnutrition (BMI <18).
  11. Exhibiting signs or symptoms of an episode of acute pancreatitis.
  12. Known allergy to secretin.
  13. Recent (within 30 days) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
  14. Use of any anticholinergic medication within 48 hours of enrollment.
  15. Any medical condition which in the judgment of the Investigator renders participation in this study medically inadvisable.
  16. Participation in an investigational clinical study for a drug or medical device within 30 days prior to Screening Visit 1.
  17. Suspected or proven Sphincter of Oddi Dysfunction.
  18. Previous pancreatic endoscopic or surgical sphincterotomy

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997476


Locations
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United States, Indiana
Indiana University; University Hospital
Indianapolis, Indiana, United States, 46202-5121
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: John M. DeWitt, M.D. Indiana University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John DeWitt, Director of Endosocpic Ultrasound, Indiana University
ClinicalTrials.gov Identifier: NCT01997476    
Other Study ID Numbers: 1105005314/1010-26
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John DeWitt, Indiana University:
Combined Endoscopic Ultrasound Morphologic Evaluation.
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases