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Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis
DOI 10.1186/ISRCTN45877994
ClinicalTrials.gov identifier
EudraCT number
Public title Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis
Scientific title Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis: a multi-centre randomised controlled trial
Acronym ESCAPE
Serial number at source DDDF (Grant nr. WO10-21) and ZonMw (Grant nr. 171102016)
Study hypothesis Early surgical intervention results in less pain over the study period and is more cost-effective than the optimal current step-up practice
Lay summary Lay summary under review 2
Ethics approval The Medical Ethical Committee of the Academic Medical Centre in Amsterdam approved on 30th March 2011
Study design A multi-centre strategy randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Chronic pancreatitis
Participants - 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
Participants - 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
Anticipated start date 01/04/2011
Anticipated end date 01/09/2014
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 88
Interventions 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
1. Step 1- Optimal medical management, if not effective followed by
2. Step 2-Endoscopic intervention, and if not effective followed by
3. Step 3- Surgical intervention

The patient follow-up will be completed 18 months after randomisation for the primary endpoint, the secondary endpoints and the other research questions.
Primary outcome measure(s) 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 outcome measure(s) 1. Cost-effectiveness, total direct and indirect costs-during 18 months follow-up period
2. Severe complications related to disease progression or endoscopic and surgical interventions
2.1. Mortality (all-cause)
2.2. Disease progression: development of pseudocysts, pancreatic insufficiency (endocrine or exocrine), gastric outlet or duodenal obstruction, chronic use of opioids (defined as need for opioids for a period > 6 months), hospital admissions for CP upflares
2.3. Endoscopic intervention: (acute) pancreatitis flare up, cholangitis, acute cholecystitis, retroperitioneal or bowel perforation, abdominal sepsis, intra-abdominal abscesses needing intervention, bleeding needing transfusion or intervention, any relaparotomy for other reasons
2.4. Surgical intervention: anastomotic leakage, bleeding needing transfusion or intervention, abdominal sepsis, intra-abdominal abscesses needing intervention, burst abdomen, severe wound infection (requiring prolonged hospital stay), any relaparotomy for other reasons
3. Quality of life-assessed by validated questionnaires.
4. Izbicki score at 18 months follow-up
5. Endocrine pancreatic insufficiency-determined by use of anti-diabetic medication or abnormal serum glucose levels (fasting serum glucose levels > 6,0 mmol/L in capillary blood or > 6,9 mmol/L in venous plasma at two different days
6. Exocrine pancreatic insufficiency-determined by fecal elastase levels (< 200µg/g)
7. Additional pain measurements-due to the heterogeneity in reporting of pain in previous trials and in order for the results of this trial to be comparable with other important trials in literature, the following additional measures of pain will be reported as well:
7.1. Proportion of patients with complete and partial pain relief at end of follow-up, defined as follows:
7.1.1. Complete pain relief: an Izbicki pain score = 10 points
7.1.2. Partial pain relief: a decrease of >50% from baseline in the Izbicki score with a final score >10 points
7.2. Visual analogue score (VAS) for pain: measured as part of the Izbicki score
7.3. Büchler pain score: alternative pain measure based on the Izbicki questionnaire, and calculated by the multiplication of two of the four items of the Izbicki questionnaire (i.e. pain frequency and pain intensity)
8. Number and duration of hospital admissions during study period-Total number of hospital admission during 18 months of follow-up period and days outside the hospital in 18 months of follow-up
9. Number of performed interventions-total number of endoscopic and surgical interventions, including initial intervention.
10. Number of pancreatitis flare ups during study period-total number during 18 months follow-up period documented by computed tomography (CT) or magnetic resonance imaging (MRI)
Sources of funding 1. Dutch Digestive Diseases Foundation (Netherlands) (ref: Grant nr. WO10-21)
2. ZonMw Health Care Efficiency Research Program (Netherlands) (ref: Grant nr. 171102016)
Trial website http://www.pancreatitis.nl/
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23506415
Contact name Dr  Marja  Boermeester
  Address Department of Surgery
Academic Medical Center Amsterdam
Postbus 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Tel +31 (0)20 566 2666
  Fax +31(0)20 566 9243
  Email M.A.Boermeester@amc.uva.nl
Sponsor Academic Medical Centre Amsterdam (Netherlands)
  Address Department of Surgery
Academic Medical Center Amsterdam
PO Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Tel +31 (0)20 566 2666
  Fax +31 (0)20 566 9243
  Email M.A.Boermeester@amc.uva.nl
  Sponsor website: http://www.amc.uva.nl/
Date applied 04/03/2011
Last edited 09/05/2013
Date ISRCTN assigned 25/03/2011
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