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

Conditions

Chronic pancreatitis Digestive System Chronic pancreatitis

Yama Issa, Marinus A. Kempeneers, Marco J. Bruno, Paul Fockens, Jan‐Werner Poley et al. (29 authors)

JAMA2020-01-21234 citations

10.1001/jama.2019.20967

Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial.

Ahmed Ali U, Issa Y, Bruno MJ, van Goor H, van Santvoort H, Busch OR, Dejong CH, Nieuwenhuijs VB, van Eijck CH, van Dullemen HM, Fockens P, Siersema PD, Gouma DJ, van Hooft JE, Keulemans Y, Poley JW, Timmer R, Besselink MG, Vleggaar FP, Wilder-Smith OH, Gooszen HG, Dijkgraaf MG, Boermeester MA, Dutch Pancreatitis Study Group.

2013-03-1852 citations

10.1186/1471-230x-13-49

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 a

Eligibility

Sex/Gender

All

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 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

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-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 (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	—

Measure

Time frame

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 (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

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Countries

Netherlands

Outcome results

None listed