1. Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis The ESCAPE Randomized Clinical Trial
- Author
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Issa, Y., Kempeneers, M.A., Bruno, M.J., Fockens, P., Poley, J.W., Ali, U.A., Bollen, T.L., Busch, O.R., Dejong, C.H., Duijvendijk, P. van, Dullemen, H.M. van, Eijck, C.H. van, Goor, H. van, 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., Hooft, J.E. van, Santvoort, H.C. van, Dijkgraaf, M.G., Boermeester, M.A., Honkoop, P., Thijssen, A.Y., Kooistra, T., Balkema, S., Bekkali, N., Boparai, K.S., Kager, L.M., Kloek, J.J., Takkenberg, R.B., Gouma, D.J., Gulik, T.M. van, Bemelman, W.A., Zwinderman, A.H., Bodelier, A.G.L., Seerden, T.C.J., Enckevort, C. van, Gils, N. van, Schoon, E., Vogelaar, L., Vries, R.S. de, Voorburg, A.M., Heisterkamp, J., Bezemer, G., Braat, H., Didden, P., Farahani, N., Flink, H.J., Koch, A.D., Postma, C., Putten, P.G. van, Reijnders, J.G.P., Roomer, R., Wiersema, U., Homans, G.L., Mares, W.G.N., Meiland, R., Erkelens, G.W., Maanen, H. van, Muller, G., Geenen, E. van, Perk, L.E., Raaf, J. de, Fransen, K., Hoedemaker, R., Meijssen, M.A.C., Hergelink, D.O., Munster, I.P. van, Romkes, T.E.H., Braat, A.E., Schaapherder, A.F.M., Kubben, F.J.G.M., Hoge, C., Masclee, A., Stassen, L.P.S., Brink, M.A., Vlerken, L. van, Kolkman, J.J., Venneman, N.G., Houdijk, A.P.J., Spek, B. van der, Jansen, J.M., The, O., Gerhards, M.F., Gooszen, H.G., Wilder-Smith, O., Hoekstra, J., Josemanders, D.F.G.M., Spanier, B.W.M., Boer, S.Y. de, Vries, E. de, Al-toma, A., Ramshorst, B. van, Weusten, B.L.A.M., Boerma, D., Bijlsma, A.R., Festen, E.A.M., Kerkhof, I., Kleibeuker, J.H., Kouw, E., Hofker, H.S., Ploeg, R., Beese, U., Siersema, P.D., Vleggaar, F.P., Molenaar, I.Q., Aktas, H., Guchelaar, I., Dutch Pancreatitis Study Grp, Gastroenterology & Hepatology, Surgery, RS: NUTRIM - R2 - Liver and digestive health, and MUMC+: MA Heelkunde (9)
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medicine.medical_specialty ,Randomization ,diagnosis ,SURGICAL DRAINAGE ,duodenum-preserving resection ,Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0] ,duct ,GUIDELINES ,01 natural sciences ,law.invention ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,03 medical and health sciences ,Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] ,0302 clinical medicine ,Superiority Trial ,All institutes and research themes of the Radboud University Medical Center ,Quality of life ,Randomized controlled trial ,law ,Internal medicine ,medicine ,MANAGEMENT ,030212 general & internal medicine ,0101 mathematics ,Pancreatitis, chronic ,therapy ,medicine.diagnostic_test ,business.industry ,010102 general mathematics ,General Medicine ,head ,medicine.disease ,Endoscopy ,Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] ,Pancreatitis ,Observational study ,business - 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
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- 2020