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.

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.

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