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

Dutch Pancreatitis Study Group

doi:https://doi.org/10.1001/jama.2019.20967

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

DSpace/Manakin Repository

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

Dutch Pancreatitis Study Group

(2020) JAMA - The Journal of The American Medical Association, volume 323, issue 3, pp. 237 - 247

(Article)

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 ... read more 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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Keywords: General Medicine

DOI: https://doi.org/10.1001/jama.2019.20967

ISSN: 0098-7484

Publisher: American Medical Association

Note: Funding Information: Funding/Support: The ESCAPE trial was funded by Funding Information: reports receipt of grants from ZonMW (governmental agency, nonprofit, Ministry of Health), MLDS (nongovernmental organization, national gastrointestinal disease association, nonprofit), and Alvleeskliervereniging (patient association of pancreatic disease, nongovernmental organization, nonprofit) during the conduct of the study. Dr Boermeester reports receipt of grants from Mylan, Acelity/KCI, Johnson & Johnson, Bard, New Compliance, and Alvleeskliervereniging; and other from Acelity/KCI (speaker, instructor, advisory board), Johnson & Johnson (speaker and advisory board), Bard (speaker), Gore (speaker and instructor), and Smith & Nephew outside the submitted work. Dr Bruno reports receipt of grants for investigator-initiated studies from Cook Medical, Pentax Medical, 3M, and Mylan; grants for industry and investigator-initiated studies from Boston Scientific; and personal fees for consultancies and lectures from Boston Scientific, from Cook Medical, Pentax Medical, 3M, and Mylan outside the submitted work. Dr Fockens reports receipt of grants from Boston Scientific and personal fees from Olympus, Cook, and Ethicon Endosurgery outside the submitted work. Dr Poley reports receipt of personal fees and other from Cook Endoscopy, Boston Scientific, and Pentax outside the submitted work. Dr van Hooft reports receipt of grants from Cook Medical and Abbott and personal fees from Boston Scientific outside the submitted work. No other disclosures were reported. Publisher Copyright: © 2020 American Medical Association. All rights reserved.

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