Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis (ESCAPE)

Not Applicable

Completed

• Conditions: Chronic pancreatitis; Digestive System

• Registration Number: ISRCTN45877994
• Lead Sponsor: Academic Medical Centre Amsterdam (Netherlands)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23506415 2020 results in: https://www.ncbi.nlm.nih.gov/pubmed/31961419 (added 22/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-25
• Study Completion: 2017-07-01
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

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 magnetic resonance cholangiopancreatography (MRCP), Computerised Tomography (CT) or Endoscopic ultrasound (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

Randomisation 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 randomisation

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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