Pancreatic Endotherapy for Refractory Chronic Pancreatitis (PERCePT)

  • STATUS
    Recruiting
  • End date
    Jul 10, 2025
  • participants needed
    30
  • sponsor
    Oregon Health and Science University
Updated on 4 October 2022

Summary

The purpose of this study is to evaluate whether endoscopic ultrasound (EUS) only versus EUS + endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy reduces pain in the treatment of chronic pancreatitis with pancreatic duct obstruction.

Description

This is a single center, pilot, sham-controlled clinical trial of ERCP with pancreatic endotherapy for pain secondary to chronic calcific pancreatitis with main pancreatic duct obstruction. Potential subjects will undergo a comprehensive baseline assessment including Quantitative Sensory Testing, to ensure enrollment criteria are met and baseline covariates are measured. Eligible subjects will complete a 14-day run-in period. If eligibility criteria persist, subjects will be randomized to diagnostic endoscopic ultrasound (EUS) + sham pancreatic endotherapy or diagnostic EUS + ERCP with pancreatic endotherapy as defined in the study protocol. Subjects will be followed by a blinded physician for the next 90 days, at which time the pilot trial outcomes will be measured. Regardless of outcomes, all subjects will be followed longitudinally for 12 months after randomization.

Details
Condition Pancreatic Duct Stone, Pancreatic Duct Stricture, Pancreatic Duct Dilatation
Treatment EUS + SHAM, EUS + Pancreatic Endotherapy
Clinical Study IdentifierNCT04232670
SponsorOregon Health and Science University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Main pancreatic duct obstruction, defined by the presence of one or both of the following features
Main pancreatic duct calcification with upstream main duct dilation ≥6mm
Main pancreatic duct stricture, defined by the presence of main pancreatic duct narrowing with upstream main duct dilation ≥6mm
Baseline average abdominal pain score ≥4 during the run-in period, based on Ecological Momentary Assessment 11-point Numeric Rating Scale
Ability to provide written, informed consent

Exclusion Criteria

Symptoms attributable to a pancreatic pseudocyst or walled off necrosis
Clinical suspicion of pancreatobiliary malignancy
Low probability of follow-up to complete study objectives
Pregnancy or incarceration
Medical comorbidities that contraindicate the performance of ERCP
Previous pancreatic endotherapy
Current Opioid Misuse Measure score ≥9
Does not have access to a mobile phone Pancreatobiliary malignancy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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