Chronic Pancreatitis
Conditions
Keywords
chronic pancreatitis, ERCP, pancreatic endocrine function, pancreatic exocrine function, diabetes, pancreatoscopy
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.
Detailed description
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.
Interventions
PROCEDUREEndoscopic 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.
Sponsors
Mayo Clinic
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From enrollment to 6 months post-randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion. | From enrollment to 6 months post-randomization | The secondary endpoint will be the change in insulin secretion from baseline to 6-months post-randomization for each treatment arm. Insulin secretion will be measured using mixed meal tolerance testing, which will be performed at baseline and 6-months post-randomization, during which serum C-peptide, insulin and glucose levels will be measured. Insulin secretion will be calculated using the Area Under the Curve (AUC) of C-peptide. This will be calculated using the trapezoidal method. An AUC of the fasting serum glucose levels will be calculated in similar fashion. Insulin secretion will then be estimated by dividing the AUC for C-peptide by the AUC for glucose. |
| Impact of pancreatic duct decompression on pancreatic exocrine function as measured by fecal elastase. | From enrollment to 6-months post-randomization | Another secondary objective is to evaluate the impact of pancreatic duct decompression on pancreatic exocrine function, as measured using the fecal elastase test. The change in fecal elastase levels from baseline to 6-months post-randomization will be compared between treatment groups to assess the change in pancreatic exocrine function. |
Contacts
CONTACTLuis Ospina, BS
PRINCIPAL_INVESTIGATORSamuel Han, MD
Mayo Clinic
Outcome results
None listed