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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -14 to day 90
Awards & highlights
PERCePT Trial 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.Check my eligibility
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.See study design
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.
PERCePT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
PERCePT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average daily pain: Numeric Rating Scale (NRS)
Secondary outcome measures
Change from baseline in pain severity and functional impairment
Conditioned pain modulation
Mechanical pain threshold
+5 morePERCePT 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).
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,246 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,846,015 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor suspects I have cancer in my pancreas or bile ducts.I am 18 years old or older.I have had treatments for my pancreas.My average stomach pain score is 4 or more.I have symptoms caused by a pancreatic cyst or dead tissue.I have health conditions that make ERCP unsafe for me.My pancreas has a blocked main duct, confirmed by tests showing duct dilation or narrowing.
Research Study Groups:
This trial has the following groups:- Group 1: EUS + SHAM
- Group 2: EUS + Pancreatic Endotherapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the patient recruitment phase of this trial still ongoing?
"Clinicaltrials.gov evidences the fact that this clinical trial is presently recruiting participants, which began on October 9th 2020 and was updated as recently as August 2nd 2022."
Answered by AI
What is the maximum capacity of participants for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this experiment is currently in the process of enrolling patients. It was first announced on October 9th 2020 and last revised on August 2nd 2022; 30 people are required across two sites."
Answered by AI
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