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Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis: A Sham-Controlled, Randomized Trial.
- Source :
-
Annals of Internal Medicine . Jun2024, Vol. 177 Issue 6, p749-758. 11p. - Publication Year :
- 2024
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Abstract
- Some patients with chronic pancreatitis experience pancreatic duct obstruction caused by stones, which may contribute to chronic abdominal pain. Although relieving this obstruction through a procedure known as extracorporeal shock-wave lithotripsy could potentially alleviate the pain, there is no high-quality evidence demonstrating the benefit of such intervention. The objective of this randomized, sham-controlled trial was to assess the efficacy and safety of pancreatic duct decompression through lithotripsy and endoscopic retrograde pancreatography. Visual Abstract. Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis: Some patients with chronic pancreatitis experience pancreatic duct obstruction caused by stones, which may contribute to chronic abdominal pain. Although relieving this obstruction through a procedure known as extracorporeal shock-wave lithotripsy could potentially alleviate the pain, there is no high-quality evidence demonstrating the benefit of such intervention. The objective of this randomized, sham-controlled trial was to assess the efficacy and safety of pancreatic duct decompression through lithotripsy and endoscopic retrograde pancreatography. 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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00034819
- Volume :
- 177
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- Annals of Internal Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 177927950
- Full Text :
- https://doi.org/10.7326/M24-0210