Pancreatic Duct StonePERCePTNCT04232670

Pancreatic Endotherapy for Refractory Chronic Pancreatitis

A study testing EUS + Pancreatic Endotherapy in people with Pancreatic Duct Stone and Pancreatic Duct Stricture, run by Oregon Health and Science University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Duct Stone, Pancreatic Duct Stricture, Pancreatic Duct Dilatation
What is being tested?: EUS + Pancreatic Endotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 2 sitesUnited States
Study dates: 9 Oct 2020to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
Oregon Health & Science University
Portland, Oregon, 97035

Other trials in United States

About this study

Read the detailed 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.

Conditions: Pancreatic Duct Stone, Pancreatic Duct Stricture, Pancreatic Duct Dilatation
Being tested: EUS + SHAM, EUS + Pancreatic Endotherapy
Keywords: pancreas, pancreatic duct, ductal stone, duct stricture, ERCP, pancreatic duct obstruction, duct calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EUS + SHAMProcedure or surgery
Endoscopic Ultrasound
EUS + Pancreatic EndotherapyProcedure or surgery
Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.

Study groups in NCT04232670
Study group	Role	What they receive
EUS + SHAM	Sham comparator	All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy). Receives: Procedure: EUS + SHAM
EUS + Pancreatic Endotherapy	Experimental	If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones. Receives: Procedure: EUS + Pancreatic Endotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Average Daily Pain Score on the Numeric Rating Scale
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.
Measured: Day -14 to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 202030 Jun 2024

First posted18 Jan 2020
Study start9 Oct 2020
Primary completion30 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic Duct StoneStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04232670
Sponsor's protocol ID: Pro00087299
Acronym: PERCePT
Status last verified: Sep 2025
First submitted: 6 Dec 2019
Last updated: 24 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Influence of Gut Microbiome in Gallstone Disease
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Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
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Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones
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Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP)
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All Pancreatic Duct Stone trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pancreatic Endotherapy for Refractory Chronic Pancreatitis
ClinicalTrials.gov ID: NCT04232670
Acronym / sponsor ID: PERCePT / Pro00087299
Conditions: Pancreatic Duct Stone, Pancreatic Duct Stricture, Pancreatic Duct Dilatation
Keywords: pancreas, pancreatic duct, ductal stone, duct stricture, ERCP, pancreatic duct obstruction, duct calcification
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 9 Oct 2020 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 18 Jan 2020 (actual)
Results: Posted 24 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EUS + SHAM	Sham comparator	Procedure: EUS + SHAMAll subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
EUS + Pancreatic Endotherapy	Experimental	Procedure: EUS + Pancreatic EndotherapyIf randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EUS + SHAMEndoscopic Ultrasound	Procedure or surgery	EUS + SHAM
EUS + Pancreatic EndotherapyPancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.	Procedure or surgery	EUS + Pancreatic Endotherapy

Primary outcome

Percent Change in Average Daily Pain Score on the Numeric Rating Scale
Time frame: 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.

Results and safety

Results posted to the registry on 24 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EUS + SHAM	6	5
EUS + Pancreatic Endotherapy	8	8

Primary outcome: Percent Change in Average Daily Pain Score on the Numeric Rating Scale

Time frame: Day -14 to Day 90. Median (Inter-Quartile Range). Unit: Percent Change

Measure	EUS + SHAM n = 4	EUS + Pancreatic Endotherapy n = 5
Value	-36.6 (-39.3 to -11.6)	-53.7 (-100.0 to -27.9)

Population analysed: The analysis population is the 9 participants who completed the Ecological Momentary Assessment (EMA) at both the start of the study and at the 90-day follow-up.

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EUS + SHAM	4 of 6 (66.7%)	0 of 6 (0%)	0 of 6
EUS + Pancreatic Endotherapy	6 of 8 (75%)	2 of 8 (25%)	0 of 8

Limitations and caveats (from the sponsor): Small sample size due to recruitment challenges \- It is difficult to recruit for the sham arm because endotherapy is widely utilized in clinical practice and advocated by expert consensus. Patients with painful chronic pancreatitis are disabled by their disease and often keen to try something even when risks are fixed and benefit unpredictable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pancreatic Duct Stone

RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
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Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Cote, MD, MS principal investigator

Oregon Health and Science University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EUS + Pancreatic Endotherapy in people with Pancreatic Duct Stone and Pancreatic Duct Stricture, run by Oregon Health and Science University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Average Daily Pain Score on the Numeric Rating Scale (time frame: Day -14 to Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04232670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.