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Not Yet Recruiting NCT07810309

Metabolic Impact of Pancreatic Duct Decompression

Conditions: Chronic Pancreatitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Mayo Clinic

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07810309). StuddyBuddy aggregates publicly available trial information.