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โ† Trials
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Metabolic Impact of Pancreatic Duct Decompression

RecruitingPhase 1Ages 18 Years - anyAllMayo Clinic
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ค 5) who do not require daily opioid pain medications * โ‰ค 1 episode of uncomplicated acute pancreatitis in 12 months prior to enrollment Exclusion Criteria: 1. History of diabetes (defined as either a HbA1c โ‰ฅ 6.5 % or a fasting glucose โ‰ฅ 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
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What it tests

  • Endoscopic pancreatic duct decompression
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Where

1 site
Mayo Clinic
Rochester, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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