Recruiting
Phase 1

Endoscopy

Sponsor:

Mayo Clinic

Code:

NCT07810309

Conditions

Chronic Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic pancreatic duct decompression

Study Details

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

Study ID

NCT07810309

Start date

Sep 30, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endoscopic pancreatic duct decompression (Intervention Arm)

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

no intervention: No endoscopic intervention (Control Arm)

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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Samuel Han, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.