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NCT04232670: PERCePT

Pancreatic Endotherapy for Refractory Chronic Pancreatitis

Completed NA Results posted Last updated 24 September 2025
What this trial tests

NA trial testing EUS + SHAM in Pancreatic Duct Stone in 14 participants. Completed in 30 June 2024.

Timeline
9 October 2020
Primary endpoint
30 June 2024
30 June 2024

Quick facts

Lead sponsorOregon Health and Science University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment14
Start date9 October 2020
Primary completion30 June 2024
Estimated completion30 June 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Oregon Health and Science University

Who can join

18 and older, any sex, with Pancreatic Duct Stone or Pancreatic Duct Stricture. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Average Daily Pain Score on the Numeric Rating Scale Primary · Day -14 to Day 90

The percent change in average daily pain score from the daily diaries during the 14-day period preceding the 90-day assessment, compared to the average daily pain reported during the 14-day run-in. The investigators employed the standardized 11-point Numeric Rating Scale (NRS) to capture average daily pain with the empirically-supported anchors of 0=No Pain and 10=Worst Pain Imaginable.

GroupValue95% CI
EUS + SHAM-36.6-39.3 – -11.6
EUS + Pancreatic Endotherapy-53.7-100.0 – -27.9

Adverse events — posted to ClinicalTrials.gov

Time frame: An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

EUS + SHAM
Serious: 4/6 (67%)
Deaths: 0/6
EUS + Pancreatic Endotherapy
Serious: 6/8 (75%)
Deaths: 0/8

Serious adverse events (16 terms)

ReactionSystemEUS + SHAMEUS + Pancreatic Endotherapy
Abdominal painGastrointestinal disorders
Chronic pancreatitisHepatobiliary disorders
Acute pancreatitis > 30 days from randomizationHepatobiliary disorders
Acute pancreatitis within 30 days of randomizationHepatobiliary disorders
Acute painGeneral disorders
Post procedural painGastrointestinal disorders
Active Suicidal IdeationPsychiatric disorders
AnaphylaxisRespiratory, thoracic and mediastinal disorders
Coronavirus infectionInfections and infestations
CostochondritisMusculoskeletal and connective tissue disorders
Elevated liver enzyme levelsHepatobiliary disorders
HyperglycemiaEndocrine disorders
SepsisInfections and infestations
Suprapubic painGastrointestinal disorders
Temporal headacheGeneral disorders
Urinary tract infectionInfections and infestations
Other adverse events (1 terms — click to expand)

ReactionSystemEUS + SHAMEUS + Pancreatic Endotherapy
Abdominal painGastrointestinal disorders

Most-reported serious reactions: Abdominal pain, Chronic pancreatitis, Acute pancreatitis > 30 days from randomization, Acute pancreatitis within 30 days of randomization, Acute pain, Post procedural pain, Active Suicidal Ideation, Anaphylaxis.

Data from ClinicalTrials.gov NCT04232670 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Management of chronic pancreatitis: recent advances and future prospects.
    Han C, Lv YW, Hu LH. · · 2024 · cited 5× · PMID 38406795 · DOI 10.1177/17562848241234480
  2. Interventions for Pancreatitis-New Approaches, Knowledge Gaps, and Research Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop.
    Phillips AE, Hughes SJ, Andersen DK, Bell A, et al · · 2024 · cited 2× · PMID 38518063 · DOI 10.1097/mpa.0000000000002333

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Other Oregon Health and Science University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04232670.

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