Relieving a blocked pancreatic duct in chronic pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized pilot trial compares endoscopic pancreatic duct decompression using ERCP (with or without ESWL) to medical management alone in adults with minimally symptomatic chronic pancreatitis and duct obstruction. Endpoints include metabolic testing of pancreatic function at baseline and six months after randomization, using mixed-meal tolerance testing. The study aims to determine if duct decompression improves endocrine and exocrine pancreatic function to inform future larger trials. Participants will undergo endoscopic treatment until duct decompression is achieved or will receive standard medical care, based on physician judgment and patient safety. The results will help clarify whether endoscopic relief of duct obstruction alters metabolic outcomes in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥ 18
4. 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
5. 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:

1. History of diabetes (defined as either a HbA1c ≥ 6.5 % or a fasting glucose ≥ 126 mg/dL)
2. Pancreatic duct obstruction limited to the tail of pancreas
3. Surgically altered forgot anatomy prohibitive of ERCP with standard techniques (e.g Billroth II, Roux-en-y gastric bypass, pancreaticoduodenectomy)
4. Prior pancreatic surgery
5. Pancreatic head mass or suspicion for pancreatic malignancy
6. Concurrent extra-pancreatic malignancy other than non-melanoma skin cancer
7. Prior endoscopic therapy for pancreatic duct obstruction
8. Acute pancreatitis \< 90 days prior to enrollment
9. Active alcohol use within 2 months of enrollment
10. Gastrointestinal stricture/obstruction precluding passage of the duodenoscope to the papilla
11. Standard contraindications to ERCP
12. Unable to receive general anesthesia

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Samuel Han, MD — Mayo Clinic
• Study coordinator: Luis Ospina, BS
• Email: OspinaVelasquez.Luis@mayo.edu
• Phone: 507-538-1827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.