Obstructive chronic pancreatitis Chronic inflammation of the pancreas caused by obstruction
Conditions
Interventions
Patients will be randomly assigned to one of two treatment groups. 
 
Group A (intervention): endoscopic therapy, including intraductal lithotripsy, aiming to achieve complete pancreatic duct clearance. In case of technical failure (e.g. inability to achieve complete du
Group B (control): surgery, including lateral pancreatico-jejunostomy. 
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For inclusion in this study, participants must fulfill all of the following criteria:Age = 18 yearsConfirmed diagnosis of chronic pancreatitis according to the M-ANNHEIM diagnostic criteria Stones and/or strictures located in the pancreatic head, neck or body, right of the left border of the vertebra on axial imaging using CT or MRIUpstream dilatation of the pancreatic duct of =5mm established with imaging (MRCP, CT, MRI or EUS)Pain as defined below Pain (one of the following)Presence of chronic moderate pain insufficiently relieved by analgetic treatment (e.g. acetaminophen, NSAIDs) defined as mean NRS score = 4, measured weekly for one month prior to inclusion Presence of chronic moderate pain requiring the use of opioids irrespective of their effect on pain relieve Presence of intermittent pain episodes (including pain-free intervals) with the following criteria: Frequency: at least 3 times in the last 12 months Pain that needs analgetic treatment with opioids for pain relieve and/or admission (pain free intervals are allowed)
Exclusion criteria
Exclusion criteria: Exclusion criteriaA potential participant who meets any of the following criteria will be excluded from participation in this study:History of prolonged need for opioids or neuropathic pain medication for chronic pancreatitis, including the need for weak opioids for >12 months and strong opioids and neuropathic pain medication for >6 months during the past year Other chronic pain syndromes that require chronic analgetic treatment with opioid medication Presence of an enlarged pancreatic head (diameter > 4 cm) based on axial imaging using CT or MRI Stones and strictures exclusively located in the proximal body or tail of the pancreas (defined anatomical landmark as left of the left border of the vertebra on axial imaging using CT or MRI) Gastric outlet obstruction, for example duodenum stenosis, or external compression by pseudocysts Common bile duct (CBD) strictures in which endoscopic stent therapy hampers the treatment of obstructive chronic pancreatitisPrevious endoscopic or surgical interventions for CP Suspected or established diagnosis of pancreatic cancer Suspected or established anatomical variations that may hamper retrograde therapy, such as Meandering Main Pancreatic Duct and Wirsungocele Contra-indications for endoscopy or surgery based on the opinion of the expert panelLife-expectancy less than 1 yearPregnancy Weak opioids: codeine, dextropropoxyphene, dihydrocodeine, tramadol and partial agonist (pentazocine, butorphanol and nalbuphine)Strong opioids: all other opioids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is pain reduction according COMPAT-SF pain score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include pain reduction using other pain scores (e.g. Izbicki pain score and VAS score), the number of adverse events, mortality rates, usage of analgesics, pancreatic endocrine and exocrine function, (radiological) disease progression, quality-of-life and healthcare utilization. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactI.J Visser
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed