Metabolic Impact of Pancreatic Duct Decompression

Metabolic Impact of Endoscopic Pancreatic Duct Decompression: A Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Procedure: Endoscopic pancreatic duct decompression

Detailed Description

This single-center randomized controlled trial will compare endoscopic pancreatic duct decompression with medical management alone for the treatment of pancreatic duct obstruction in patients with minimally symptomatic chronic pancreatitis. Utilizing mixed-meal tolerance testing, endocrine function will be assessed at baseline and 6-months post-randomization. We hypothesize that rigorous metabolic testing using mixed-meal tolerance testing at baseline and 6-months post-randomization will be feasible.

The study intervention entails endoscopic pancreatic duct decompression which entails endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shock wave lithotripsy (ESWL). Endoscopic treatment via ERCP ± ESWL will continue until pancreatic duct decompression is achieved. The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Luis Ospina, BS; Phone Number: 507-538-1827; Email: OspinaVelasquez.Luis@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Participants in the intervention arm will receive endoscopic pancreatic duct decompression.	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.
No Intervention: Control Arm; The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to 6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion.	The secondary endpoint will be the change in insulin secretion from baseline to 6-months post-randomization for each treatment arm. Insulin secretion will be measured using mixed meal tolerance testing, which will be performed at baseline and 6-months post-randomization, during which serum C-peptide, insulin and glucose levels will be measured. Insulin secretion will be calculated using the Area Under the Curve (AUC) of C-peptide. This will be calculated using the trapezoidal method. An AUC of the fasting serum glucose levels will be calculated in similar fashion. Insulin secretion will then be estimated by dividing the AUC for C-peptide by the AUC for glucose.	From enrollment to 6 months post-randomization
Impact of pancreatic duct decompression on pancreatic exocrine function as measured by fecal elastase.	Another secondary objective is to evaluate the impact of pancreatic duct decompression on pancreatic exocrine function, as measured using the fecal elastase test. The change in fecal elastase levels from baseline to 6-months post-randomization will be compared between treatment groups to assess the change in pancreatic exocrine function.	From enrollment to 6-months post-randomization

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Indiana University
• Investigators: Principal Investigator: Samuel Han, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; ERCP; chronic pancreatitis; pancreatoscopy; pancreatic endocrine function; pancreatic exocrine function
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Pancreatitis; Pancreatitis, Chronic; Diabetes Mellitus
• Other Study ID Numbers: 26-005624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data including participant and disease characteristics and treatment outcomes will be shared.
• IPD Sharing Time Frame: 24 months after publication of primary manuscript to 5 years after publication of primary manuscript.

IPD Sharing Access Criteria

Researchers will be able to access the IPD after submitting a proposal that is reviewed and approved by the PI.

Deidentified data in accordance to the agreed-upon proposal will be made available to researchers.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes