Digital single-operator pancreatoscopy for the treatment of symptomatic pancreatic duct stones: a prospective multicenter cohort trial

Abstract

Background Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones.

Methods Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs).

Results 40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively.

Conclusion DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients.

• References

• 1 Lohr JM, Dominguez-Munoz E, Rosendahl J. et al. United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU). United European Gastroenterol J 2017; 5: 153-199
• 2 Anderson MA, Akshintala V, Albers KM. et al. Mechanism, assessment and management of pain in chronic pancreatitis: Recommendations of a multidisciplinary study group. Pancreatology 2016; 16: 83-94
• 3 Kitano M, Gress TM, Garg PK. et al. International consensus guidelines on interventional endoscopy in chronic pancreatitis. Recommendations from the working group for the international consensus guidelines for chronic pancreatitis in collaboration with the International Association of Pancreatology, the American Pancreatic Association, the Japan Pancreas Society, and European Pancreatic Club. . Pancreatology 2020; 20: 1045-1055
• 4 Gerges C, Pullmann D, Schneider M. et al. Pancreatoscopy in endoscopic treatment of pancreatic duct stones: a systematic review. Minerva Chir 2019; 74: 334-347
• 5 Beyna T, Neuhaus H, Gerges C. Endoscopic treatment of pancreatic duct stones under direct vision: Revolution or resignation? Systematic review. . Dig Endosc 2018; 30: 29-37
• 6 Drewes AM, Bouwense SAW, Campbell CM. et al. Guidelines for the understanding and management of pain in chronic pancreatitis. Pancreatology 2017; 17: 720-731
• 7 Rösch T, Daniel S, Scholz M. et al. Endoscopic treatment of chronic pancreatitis: a multicenter study of 1000 patients with long-term follow-up. Endoscopy 2002; 34: 765-771
• 8 Dumonceau JM, Delhaye M, Tringali A. et al. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Updated August 2018. Endoscopy 2019; 51: 179-193
• 9 Tandan M, Talukdar R, Reddy DN. Management of pancreatic calculi: an update. Gut Liver 2016; 10: 873-880
• 10 McCarty TR, Sobani Z, Rustagi T. Per-oral pancreatoscopy with intraductal lithotripsy for difficult pancreatic duct stones: a systematic review and meta-analysis. Endosc Int Open 2020; 8: E1460-E1470
• 11 Gerges C, Pullmann D, Bahin F. et al. SpyGlassDS guided lithotripsy for pancreatic duct stones in symptomatic treatment refractory chronic calcifying pancreatitis. Endosc Int Open 2019; 7: E99-E103
• 12 Izbicki JR, Bloechle C, Broering DC. et al. Longitudinal V-shaped excision of the ventral pancreas for small duct disease in severe chronic pancreatitis: prospective evaluation of a new surgical procedure. Ann Surg 1998; 227: 213-219
• 13 Dumonceau JM, Kapral C, Aabakken L. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2020; 52: 127-149
• 14 Dominguez-Munoz JE, Drewes AM, Lindkvist B. et al. Recommendations from the United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis. Pancreatology 2018; 18: 847-854
• 15 Guda NM, Partington S, Freeman ML. Extracorporeal shock wave lithotripsy in the management of chronic calcific pancreatitis: a meta-analysis. JOP 2005; 6: 6-12
• 16 Gerges C, Pullmann D, van Geenen E. et al. Digital single-operator video pancreatoscopy (SpyGlassDS) with lithotripsy in chronic calcifying pancreatitis with obstructing stone of the main pancreatic duct: retrospective series of 23 cases. Endoscopy 2018; 50: S81-S82
• 17 Brewer Gutierrez OI, Raijman I, Shah RJ. et al. Safety and efficacy of digital single-operator pancreatoscopy for obstructing pancreatic ductal stones. Endosc Int Open 2019; 7: E896-E903
• 18 Ogura T, Okuda A, Imanishi M. et al. Electrohydraulic lithotripsy for pancreatic duct stones under digital single-operator pancreatoscopy (with video). Dig Dis Sci 2019; 64: 1377-1382
• 19 Tandan M, Nageshwar Reddy D, Talukdar R. et al. ESWL for large pancreatic calculi: Report of over 5000 patients. Pancreatology 2019; 19: 916-921
• 20 Cahen DL, Gouma DJ, Nio Y. et al. Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis. NEJM 2007; 356: 676-684
• 21 Issa Y, Kempeneers MA, Bruno MJ. et al. Effect of early surgery vs endoscopy-first approach on pain in patients with chronic pancreatitis: the ESCAPE randomized clinical trial. JAMA 2020; 323: 237-247
• 22 Drake M, Dodwad SJ, Davis J. et al. Sex-related differences of acute and chronic pancreatitis in adults. J Clin Med 2021; 10: 300
• 23 Dumonceau JM, Costamagna G, Tringali A. et al. Treatment for painful calcified chronic pancreatitis: extracorporeal shock wave lithotripsy versus endoscopic treatment: a randomised controlled trial. Gut 2007; 56: 545-552