1. Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis : A Sham-Controlled, Randomized Trial.
- Author
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Talukdar R, Olesen SS, Unnisa M, Bedarkar A, Sarkar S, Tandan M, Jagtap N, Darisetty S, Kiran S, Koppoju V, Lakhtakia S, Ramchandani M, Kalapala R, Gupta R, Singh VK, Rao GV, Reddy DN, and Drewes AM
- Subjects
- Humans, Male, Female, Middle Aged, Adult, Pain Measurement, Abdominal Pain etiology, Abdominal Pain therapy, Pain Management methods, Treatment Outcome, Pancreatitis, Chronic complications, Pancreatitis, Chronic therapy, Lithotripsy adverse effects, Lithotripsy methods, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Pancreatic Ducts diagnostic imaging
- Abstract
Background: No randomized controlled trials have substantiated endoscopic decompression of the pancreatic duct in patients with painful chronic pancreatitis., Objective: To investigate the pain-relieving effect of pancreatic duct decompression in patients with chronic pancreatitis and intraductal stones., Design: 24-week, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT03966781)., Setting: Asian Institute of Gastroenterology in India from February 2021 to July 2022., Participants: 106 patients with chronic pancreatitis., Intervention: Combined extracorporeal shock-wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with sham procedures., Measurements: The primary end point was pain relief on a 0- to 10-point visual analog scale (VAS) at 12 weeks. Secondary outcomes were assessed after 12 and 24 weeks and included 30% pain relief, opioid use, pain-free days, questionaries, and complications to interventions., Results: 52 patients in the ESWL/ERP group and 54 in the sham group were included. At 12 weeks, the ESWL/ERP group showed better pain relief compared with the sham group (mean difference in change, -0.7 [95% CI, -1.3 to 0] on the VAS; P = 0.039). The difference between groups was not sustained at the 24-week follow-up, and no differences were seen for 30% pain relief at 12- or 24-week follow-up. The number of pain-free days was increased (median difference, 16.2 days [CI, 3.9 to 28.5 days]), and the number of days using opioids was reduced (median difference, -5.4 days [CI, -9.9 to -0.9 days]) in the ESWL/ERP group compared with the sham group at 12-week follow-up. Safety outcomes were similar between groups., Limitation: Single-center study and limited duration of follow-up., Conclusion: In patients with chronic pancreatitis and intraductal stones, ESWL with ERP provided modest short-term pain relief., Primary Funding Source: Asian Institute of Gastroenterology and Aalborg University Hospital., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M24-0210.
- Published
- 2024
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