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Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis : A
Rupjyoti Talukdar1, Søren S Olesen2, Misbah Unnisa1
1Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India (R.T., M.U., A.B., S.S., M.T., N.J., S.L., M.R., R.K., R.G., D.N.R.).
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.
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