Chronic pancreatitis Chronic pancreatitis
Conditions
Interventions
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. At least 18 years old 2. Indication for lateral pancreaticojejunostmy as agreed during multidisciplinary team meeting based on symptomatic CP (i.e. morphine dependent pain or recurrent acute pancreatitis) 3. Dilated pancreatic duct of >= 5 mm, without enlarged pancreatic head < 40 mm 4. Confirmed CP, according to the M-ANNHEIM diagnostic Criteria22 • Typical clinical history of chronic pancreatitis (i.e. recurrent pancreatitis or abdominal pain), and: • One or more of the following additional criteria for the diagnosis of CP: o Pancreatic calcifications on CT or MRI imaging. o Moderate or marked ductal lesions (according to the Cambridge classification) on endoscopic retrograde cholangiopancreatography (ERCP) or magnetic resonance cholangiopancreatography (MRCP) imaging. o Marked and persistent exocrine insufficiency (defined as: a. pancreatic steatorrhea clearly relieved by enzyme supplementation, and/or b. fecal elastase levels of <= 200 micro gram/gram). 5. Eligible for both a robot-assisted and open approach 6. Obtained written informed consent
Exclusion criteria
Exclusion criteria: 1. Suspected or confirmed current pancreatic malignancy 2. Known allergy / contraindication for epidural anesthesia 3. ASA classification >= 4 4. Other painful conditions aside from chronic pancreatitis, making it unable differentiate between pain related to chronic pancreatitis and pain stemming from other sources 5. Prior pancreatic surgery 6. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Quality of recovery as measured by the QoR-15. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: blood loss, total operative time, complications (surgical site infection, delayed gastric emptying, postoperative pancreatic fistula, postpancreatectomy haemorrhage), cumulative opioid consumption, all-cause mortality, time to functional recovery, area under the curve of QoR-15 until conditions of time to functional recovery are met, hospital stay, readmission(s) for any indication, quality of life, costs, endoscopic interventions, surgical interventions, new-onset endocrine pancreatic insufficiency, new-onset exocrine pancreatic insufficiency, pain (Izbicki pain score, COMPAT, NRS), disease progression. | — |
Countries
Germany, Netherlands
Contacts
Public ContactE. Kilinc
Amsterdam UMC
Outcome results
None listed