Chronic pancreatitis
Conditions
Interventions
Intervention group:
Early surgical intervention: Surgical drainage of the pancreatic duct (pancreaticojejunostomy) if pancreatic head is not enlarged (< 4 cm)
or surgical drainage of the pancreatic duct and resection of the head of the pancreas (Frey procedure) if pancreatic head is enlarged (4cm).
Control group:
Optimal current step-up practice:
Step 1:
Step 2: Endoscopic intervention, and if not effective followed by
Step 3: Surgical intervention.
Sponsors
Academic Medical Center Amsterdam
Department of Surgery
PO Box 22660, 1100 DD Amsterdam
Tel: +31205662666
Fax: +31205669243
Eligibility
Inclusion criteria
Inclusion criteria: Registration criteria: 1. Age 18 years; 2. Confirmed chronic pancreatitis: according to the M-ANNHEIM diagnostic criteria; 3. Dilated pancreatic duct (5 mm, established by MRCP, CT or EUS), with or without enlargement of the pancreatic head; 4. Presence of moderate, non-debilitating pain. This will be defined as chronic abdominal pain (present for at least 3 months) sufficiently relieved with non-opioid analgesics. Randomization criteria (after fulfilling inclusion criteria for registration): 1. Need for upgrade from non-opioids to opioid analgesics: newly developed need for opioids analgesics (opioids needed at least 3 days per week) and persistently needed for at least 2 weeks in a row; 2. Informed consent for randomization.
Exclusion criteria
Exclusion criteria: 1. History of prolonged need of opioids for chronic pancreatitis for a period over 2 months in the last 2 years; 2. Previous pancreatic surgery; 3. Previous endoscopic dilatation or stenting of the pancreatic duct; 4. Episode of biliary obstruction in the last 2 months (defined as jaundice or bilirubine levels 25 micromol / L) or the presence of a stent in the common bile duct (CBD); 5. Proven autoimmune pancreatitis (including elevated levels of gamma-globulins (IgG)); 6. Suspected or established pancreatic malignancies; 7. Life expectancy of < 1 year for any reason; 8. Presence of duodenal obstruction necessitating surgery, as judged by the expert panel; 9. Presence of a pseudocyst larger than 6 cm necessitating intervention, as judged by the expert panel; 10. Contra-indications for surgery, always evaluated by the expert panel (e.g. American Society of Anesthesiology class IV, severe portal hypertension due to occluded portal vein); 11. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical outcome is the degree of pain as assessed by the Izbicki pain score at 2 weeks intervals during the follow-up period of 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost-effectiveness, total direct and indirect costs; 2. Severe complications related to disease progression, or endoscopic and surgical interventions; 3. Quality of life; 4. Izbicki score at 18 months follow-up; 5. Endocrine pancreatic insufficiency; 6. Exocrine pancreatic insufficiency; 7. Additional pain measurements; 8. Number and duration of hospital admissions during study period; 9. Number of performed interventions; 10. Number of pancreatitis flair ups during study period. | — |
Contacts
Public ContactY. Issa
Radboud University Nijmegen Medical Centre Dutch Pancreatitis Study Group Department of Surgery, HP 690 PO Box 9101
Outcome results
None listed