Condition category
Digestive System
Date applied
04/03/2011
Date assigned
25/03/2011
Last edited
09/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

http://www.pancreatitis.nl/

Contact information

Type

Scientific

Primary contact

Dr Marja Boermeester

ORCID ID

Contact details

Department of Surgery
Academic Medical Center Amsterdam
Postbus 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2666
M.A.Boermeester@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DDDF (Grant nr. WO10-21) and ZonMw (Grant nr. 171102016)

Study information

Scientific title

Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis: a multi-centre randomised controlled trial

Acronym

ESCAPE

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Chronic pancreatitis

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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)

Overall trial start date

01/04/2011

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

88

Participant 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

Recruitment start date

01/04/2011

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Surgery
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre Amsterdam (Netherlands)

Sponsor details

Department of Surgery
Academic Medical Center Amsterdam
PO Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2666
M.A.Boermeester@amc.uva.nl

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Government

Funder name

Dutch Digestive Diseases Foundation (Netherlands) (ref: Grant nr. WO10-21)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ZonMw Health Care Efficiency Research Program (Netherlands) (ref: Grant nr. 171102016)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23506415

Publication citations

  1. Protocol

    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, , Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial., BMC Gastroenterol, 2013, 13, 49, doi: 10.1186/1471-230X-13-49.

Additional files

Editorial Notes