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Cited by 261Pancreatitis Pathology and TreatmentGallbladder and Bile Duct DisordersPancreatic and Hepatic Oncology Research

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Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial

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Issa, Yama, Kempeneers, Marinus A., Bruno, Marco J., Fockens, Paul, Poley, Jan-Werner, Ahmed Ali, Usama, Bollen, Thomas L., Busch, Olivier R., Dejong, Cees H., van Duijvendijk, Peter, van Dullemen, Hendrik M., van Eijck, Casper H., van Goor, Harry, Hadithi, Muhammed, Haveman, Jan-Willem, Keulemans, Yolande, Nieuwenhuijs, Vincent B., Poen, Alexander C., Rauws, Erik A., Tan, Adriaan C., Thijs, Willem, Timmer, Robin, Witteman, Ben J., Besselink, Marc G., van Hooft, Jeanin E., van Santvoort, Hjalmar C., Dijkgraaf, Marcel G., Boermeester, Marja A., for the Dutch Pancreatitis Study Group·2020·JAMA
DOI 10.1001/jama.2019.20967PMC PMC6990680
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Abstract

Importance: For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function. Objective: To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes. Design, Setting, and Participants: The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018. Interventions: There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed. Main Outcomes and Measures: The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality. Results: Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, -12 points [95% CI, -22 to -2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach. Conclusions and Relevance: Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings. Trial Registration: ISRCTN Identifier: ISRCTN45877994.

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Authors
Issa, Y., Kempeneers, M. A., Bruno, M. J., Fockens, P., Poley, J.-W., Ahmed Ali, U., Bollen, T. L., Busch, O. R., Dejong, C. H., van Duijvendijk, P., van Dullemen, H. M., van Eijck, C. H., van Goor, H., Hadithi, M., Haveman, J.-W., Keulemans, Y., Nieuwenhuijs, V. B., Poen, A. C., Rauws, E. A., Tan, A. C., Thijs, W., Timmer, R., Witteman, B. J., Besselink, M. G., van Hooft, J. E., van Santvoort, H. C., Dijkgraaf, M. G., Boermeester, M. A., & for the Dutch Pancreatitis Study Group
Affiliations
  • Amsterdam University Medical Centers (NL)
  • Erasmus MC (NL)
  • Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
  • St. Antonius Ziekenhuis (NL)
  • Maastricht University Medical Centre (NL)
  • Department of Surgery, Gelre Hospital, Apeldoorn, the Netherlands
  • Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
  • Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, the Netherlands
  • Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands
  • Maasstad Ziekenhuis (NL)
  • University Medical Center Groningen (NL)
  • Zuyderland Medisch Centrum (NL)
  • Isala (NL)
  • Canisius-Wilhelmina Ziekenhuis (NL)
  • Martini Ziekenhuis (NL)
  • Ziekenhuis Gelderse Vallei (NL)
  • Department of Gastroenterology and Hepatology; Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
  • Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands
  • Amsterdam Public Health (NL)
Corresponding author
Boermeester, Marja A.
ORCID
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2020-01-21
Volume
323
Issue
3
Pages
237
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.2019.20967
PMC
PMC6990680
OpenAlex
W3001391521
Cited by
261
References
29
Citations by year
2026: 34 · 2025: 41 · 2024: 50 · 2023: 41 · 2022: 34 · 2021: 39 · 2020: 22
FWCI
31.07
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Pure Amsterdam UMC (publishedVersion, other-oa)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
  • Research Publications (Maastricht University) (acceptedVersion, other-oa)
  • Leiden Repository (Leiden University) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • RWTH Publications (RWTH Aachen) (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
  • Radboud Repository (Radboud University) (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
  • Research Publications (Maastricht University) (submittedVersion, other-oa)
Funders
  • ZonMw (17110216)
  • Maag Lever Darm Stichting
Topics
  • Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
  • Health Sciences › Medicine › Gastroenterology › Gallbladder and Bile Duct Disorders
  • Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Keywords
chronic pancreatitis, early surgical intervention, pancreatic drainage, pain management, pancreatic duct dilatation, pancreatic function, quality of life, surgical complications, mortality, ESCAPE trial, opioid use, endoscopic lithotripsy, pancreatic resection, pancreatic exocrine function, pancreatic ductal adenocarcinoma
MeSH terms
Adult, Analgesics, Opioid, Calculi, Drainage, Endoscopy, Female, Humans, Lithotripsy, Male, Middle Aged, Pain, Pain Measurement, Pancreatic Ducts, Area Under Curve, Pancreatitis, Chronic, Pain Management

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