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

Dutch Pancreatitis Study Grp, 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., 21-Jan-2020, In : JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. 323, 3, p. 237-247 11 p.

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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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DOI

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

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

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.

Original languageEnglish
Pages (from-to)237-247
Number of pages11
JournalJAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Volume323
Issue number3
Publication statusPublished - 21-Jan-2020

    Keywords

  • DUODENUM-PRESERVING RESECTION, SURGICAL DRAINAGE, DUCT, THERAPY, GUIDELINES, MANAGEMENT, DIAGNOSIS, HEAD

ID: 116935144