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Pancreatic Endotherapy for Chronic Pancreatitis (PERCePT Trial)

N/A

Waitlist Available

Led By Gregory Cote, MD, MS

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Baseline average abdominal pain score ≥4 during the run-in period, based on Ecological Momentary Assessment 11-point Numeric Rating Scale

Must not have

Clinical suspicion of pancreatobiliary malignancy

Previous pancreatic endotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -14 to day 90

Summary

This trial is testing whether treating chronic pancreatitis with just endoscopic ultrasound (EUS) is more effective at reducing pain than adding endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy.

Who is the study for?

This trial is for adults over 18 with chronic pancreatitis, who have a blockage in the main pancreatic duct. Participants must be experiencing significant abdominal pain and able to give informed consent. It's not for pregnant individuals, prisoners, those without mobile phone access, people with pancreatic cancer or high risk of it, previous endotherapy patients, or if they're likely to miss follow-up appointments.

What is being tested?

The study is testing two approaches: one group will receive an ultrasound-guided procedure (EUS) only; the other will get EUS plus a specialized procedure called ERCP with pancreatic endotherapy. The goal is to see which method better reduces pain from blocked pancreatic ducts.

What are the potential side effects?

Potential side effects may include discomfort at the site of intervention, infection risks associated with procedures like ERCP, possible pancreatitis flare-ups post-procedure and complications related to sedation used during these procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My average stomach pain score is 4 or more.

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My pancreas has a blocked main duct, confirmed by tests showing duct dilation or narrowing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor suspects I have cancer in my pancreas or bile ducts.

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I have had treatments for my pancreas.

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I have symptoms caused by a pancreatic cyst or dead tissue.

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I have health conditions that make ERCP unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -14 to day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -14 to day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -14 to day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average daily pain: Numeric Rating Scale (NRS)

Secondary study objectives

Change from baseline in pain severity and functional impairment

Conditioned pain modulation

Mechanical pain threshold

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EUS + Pancreatic EndotherapyExperimental Treatment1 Intervention

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.

Group II: EUS + SHAMPlacebo Group1 Intervention

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).

0 / 7Eligibility criteria met