A Study Of Pancreatic Duct Decompression

Overview

About this study

The purpose of this study is to demonstrate the feasibility of rigorous metabolic testing in a randomized-controlled trial in patients with minimally symptomatic chronic obstructive pancreatitis.   

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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; 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

  • Age < 18 years, pregnancy, incarceration, unwillingness/inability to provide informed consent, or anticipated inability to follow protocol

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 05/12/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Samuel Han, M.D.

Contact us for the latest status

Contact information:

Allison Ajke

5075387941

ajke.allison@mayo.edu

More information

Publications

Publications are currently not available