NCT07810309 · Mayo Clinic
Metabolic Impact of Pancreatic Duct Decompression
What this study is about
This study is a pilot study evaluating the impact of clearing out the pancreatic duct in patients with chronic pancreatitis who have a blockage in their pancreatic duct.
View original scientific description
This study is a pilot study evaluating the impact of clearing out the pancreatic duct in patients with chronic pancreatitis who have a blockage in their pancreatic duct. While we typically perform procedures with an endoscope (a long flexible tube with a camera that goes through the mouth to reach the small intestine) to relieve a pancreatic duct blockage in patients with chronic pancreatitis who have pain and have a blockage, we do not know how relieving this blockage improves pancreatic function. Therefore, we are performing a preliminary study where participants will be randomized to either receiving an endoscopy or not undergoing an endoscopy. This will provide some background data to help inform us whether we should perform a larger study in the future to answer this question.
Interventions
PROCEDURE
Endoscopic pancreatic duct decompression
The study intervention is endoscopic pancreatic duct decompression, which will consist of endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shockwave lithotripsy (ESWL). Treatment via ERCP +/- ESWL can be continued for multiple treatment sessions until the pancreatic duct has been decompressed, defined as complete resolution of the PD stricture (defined as \> 90% resolution of the stenosis on pancreatography) and/or complete stone clearance (\> 90% removal of PD stones) of any PD stones. Pancreatoscopy-guided lithotripsy can be performed during ERCP as well to help aid in stricture or stone therapy.
Primary outcome measures
Feasibility of performing randomized-controlled trial in patients with minimally symptomatic chronic pancreatitis to assess metabolic function as defined via enrollment ratio, retention rate, and assessment completion rate.
Time frame: From enrollment to 6 months post-randomization
Feasibility will be defined as follows: For the study enrollment ratio, the total number of participants referred will form the denominator for the enrollment ratio, while the number of enrolled will form the numerator for the enrollment ratio. A 50% enrollment ratio will be indicative of feasibility. Retention will be determined by the proportion of enrolled participants who remain in the study until completion of endotherapy and the end of assessment period. A 75% retention rate will be indicative of feasibility. Assessment completion will be defined as completion of all baseline assessments and 6-months post-randomization assessments, including all metabolic tests. Participants who complete all assessments represent the numerators in the assessment completion ratio with the number of participants enrolled serving as the denominator in the assessment completion ratio. A 70% completion rate will indicate feasibility.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18
- Chronic pancreatitis as defined by Cambridge grade 3 or 4 (3: \> 3 abnormal side branches; 4: abnormal main duct and branches) pancreatic ductal changes and/or parenchymal and/or intraductal calcifications (chronic calcific pancreatitis) by CT Scan or MRI/MRCP24
- Minimally symptomatic:
- Asymptomatic patients who were incidentally diagnosed with chronic pancreatitis based on imaging
- Mild to moderate pain (visual analog scale ≤ 5) who do not require daily opioid pain medications
- ≤ 1 episode of uncomplicated acute pancreatitis in 12 months prior to enrollment
Exclusion criteria
- History of diabetes (defined as either a HbA1c ≥ 6.5 % or a fasting glucose ≥ 126 mg/dL)
- Pancreatic duct obstruction limited to the tail of pancreas
- Surgically altered forgot anatomy prohibitive of ERCP with standard techniques (e.g Billroth II, Roux-en-y gastric bypass, pancreaticoduodenectomy)
- Prior pancreatic surgery
- Pancreatic head mass or suspicion for pancreatic malignancy
- Concurrent extra-pancreatic malignancy other than non-melanoma skin cancer
- Prior endoscopic therapy for pancreatic duct obstruction
- Acute pancreatitis \< 90 days prior to enrollment
- Active alcohol use within 2 months of enrollment
- Gastrointestinal stricture/obstruction precluding passage of the duodenoscope to the papilla
- Standard contraindications to ERCP
- Unable to receive general anesthesia
Where
- Rochester, Minnesota
Collaborators
Indiana University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations