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Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis
abstract
This abstract is available on the publisher's site.
Access this abstract nowImportance
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.
Additional Info
Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial
JAMA 2020 Jan 21;323(3)237-247, Y Issa, MA Kempeneers, MJ Bruno, P Fockens, JW Poley, U Ahmed Ali, TL Bollen, OR Busch, CH Dejong, P van Duijvendijk, HM van Dullemen, CH van Eijck, H van Goor, M Hadithi, JW Haveman, Y Keulemans, VB Nieuwenhuijs, AC Poen, EA Rauws, AC Tan, W Thijs, R Timmer, BJ Witteman, MG Besselink, JE van Hooft, HC van Santvoort, MG Dijkgraaf, MA BoermeesterFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Current management paradigms for painful, chronic pancreatitis involve a multidisciplinary step-up approach consisting of medical therapy, followed by endotherapy, and then surgery as a last resort.1,2 The Dutch pancreatitis group challenged this paradigm through a well-conducted, multicenter, randomized, controlled trial and compared early surgery with an endoscopy-first approach. Surgery consisted of conventional drainage or resection procedures and did not include total pancreatectomy with islet autotransplantation (TPIAT), which is an increasingly applied therapy for hereditary, refractory, and small-duct chronic pancreatitis and with islet cell yields substantially impaired by prior drainage operations.3 Endoscopic therapy included ESWL and standard endoscopic interventions but did not include pancreatoscopy with intraductal lithotripsy techniques for extraction of pancreatic stones, which is an increasingly utilized and more effective technique for achieving complete duct clearance.4
In the ESCAPE study, surgery resulted in lower pain scores with fewer interventions when patients were followed over 18 months. However, when the pancreatic duct was completely cleared endoscopically, pain improvement was similar in the endoscopic and surgical group (Izbicki pain score, 40 vs 37; Supplement 2). Furthermore, improvement in pain was not close to complete in either group.
Thus, although well conducted, the ESCAPE trial compares somewhat outdated modalities for management of chronic pancreatitis. In a more modern algorithm, potential candidates for ultimate TPIAT, such as those with hereditary disease, may be best served by a maximally effective trial of endoscopic therapy, with conventional surgery reserved for patients unsuitable for either current modalities of endoscopic therapy or eventual TPIAT.
References