Rupjyoti Talukdar et al., 2024: Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis : A Sham-Controlled, Randomized Trial

Rupjyoti Talukdar 1 , Søren S Olesen 2 , Misbah Unnisa 1 , Akshay Bedarkar 1 , Subhaleena Sarkar 1 , Manu Tandan 1 , Nitin Jagtap 1 , Santosh Darisetty 3 , Sekhramantri Kiran 4 , Vinod Koppoju 4 , Sundeep Lakhtakia 1 , Mohan Ramchandani 1 , Rakesh Kalapala 1 , Rajesh Gupta 1 , Vikesh K Singh 5 , Guduru Venkat Rao 6 , Duvvur Nageshwar Reddy 1 , Asbjørn M Drewes 2
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.).
2Centre for Pancreatic Diseases & Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Aalborg, Denmark (S.S.O., A.M.D.).
3Department of Anesthesia, Asian Institute of Gastroenterology, Hyderabad, Telangana, India (S.D.).
4Lithotripsy Unit, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India (S.K., V.K.).
5Pancreatitis Center, Division of Gastroenterology, Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland (V.K.S.).
6Department of Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India (G.V.R.).

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.

Ann Intern Med. 2024 May 28. doi: 10.7326/M24-0210. Online ahead of print. PMID: 38801774