Metabolic Impact of Pancreatic Duct Decompression

NCT07810309 | Recruiting Phase 1

• 1 other identifier: 26-005624
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; ERCP; pancreatic endocrine function; pancreatic exocrine function; diabetes; pancreatoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion.

  From enrollment to 6 months post-randomization

• Impact of pancreatic duct decompression on pancreatic exocrine function as measured by fecal elastase.

  From enrollment to 6-months post-randomization

Study Arms (2)

Endoscopic pancreatic duct decompression (Intervention Arm)

EXPERIMENTAL

Participants in the intervention arm will receive endoscopic pancreatic duct decompression.

Procedure: Endoscopic pancreatic duct decompression

No endoscopic intervention (Control Arm)

NO INTERVENTION

The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.

Interventions

Endoscopic pancreatic duct decompression PROCEDURE

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.

Endoscopic pancreatic duct decompression (Intervention Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Indiana University: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Samuel Han, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Ospina, BS

CONTACT

507-538-1827; OspinaVelasquez.Luis@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized-controlled trial

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 9, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 24 months after publication of primary manuscript to 5 years after publication of primary manuscript.
• 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.

Locations

US (1)