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

NCT01997476 | Completed DMC

• 1 other identifier: 1105005314/1010-26
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Disease

Keywords

Combined Endoscopic Ultrasound Morphologic Evaluation.

Outcome Measures

Primary Outcomes (1)

• Combined Endoscopic Ultrasound Morphologic Evaluation, Endoscopic Pancreatic Function Testing (ePFT), and Dynamic EUS Ductal Evaluation (sEUS)

  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

  48 months (anticipated)

Secondary Outcomes (1)

• Advantage of combining EUS and ePFT to provide a more definitive diagnostic assessment, rather than each test alone.

  48 months (anticipated).

Study Arms (1)

Combined EUS, e-PFT and sEUS Testing

EXPERIMENTAL

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

Interventions

Combined EUS, e-PFT and sEUS Testing PROCEDURE

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.

Combined EUS, e-PFT and sEUS Testing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between the ages of 18-80 years old.
• Clinical suspicion of pancreatic exocrine disease.
• 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.
• EUS and ePFT planned for structural and functional evaluation of the exocrine pancreas.
• Ability to undergo conscious sedation or monitored anesthesia.
• Willing and able to sign written informed consent.

You may not qualify if:

• Symptoms of acute pancreatitis within 30 days of the combined function test.
• Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
• Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
• Severe renal disease (history of acute or chronic renal failure and/or dialysis dependent and/or baseline creatinine \>2.0 mg/dL).
• Pregnant or nursing.
• Ongoing illicit drug use or abuse.
• Ongoing moderate or severe alcohol use defined by greater than 30 grams alcohol/day.
• Acute pancreatitis as defined by the Atlanta Classification definition (see Appendix D) within the previous two months.
• Prior pancreatic surgery.
• 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).
• Exhibiting signs or symptoms of an episode of acute pancreatitis.
• Known allergy to secretin.
• Recent (within 30 days) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
• Use of any anticholinergic medication within 48 hours of enrollment.
• Any medical condition which in the judgment of the Investigator renders participation in this study medically inadvisable.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University; University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

Related Publications (1)

• DeWitt JM, Al-Haddad MA, Easler JJ, Sherman S, Slaven J, Gardner TB. EUS pancreatic function testing and dynamic pancreatic duct evaluation for the diagnosis of exocrine pancreatic insufficiency and chronic pancreatitis. Gastrointest Endosc. 2021 Feb;93(2):444-453. doi: 10.1016/j.gie.2020.06.029. Epub 2020 Jun 17.

  PMID: 32562609 DERIVED

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• John M. DeWitt, M.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endosocpic Ultrasound

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 28, 2013
• Study Start: September 1, 2012
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: March 19, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)