Covered self-expandable metal stents for pancreatic duct stricture: a systematic review and meta-analysis

Abstract

Background and study aims Placement of a covered (C)-self-expandable metal stent (SEMS) has been recently investigated as an alternative endoscopic treatment for main pancreatic duct stricture (MPDS) in chronic pancreatitis. Our aim was to carry out a systematic review and meta-analysis of studies quantifying efficacy and safety of C-SEMSs in the management of MPDS.

Methods A multiple database search was performed, including MEDLINE, Embase and Cochrane Library, from January 2000 to September 2020, to identify studies reporting the efficacy and safety of C-SEMSs in patients with MPDS. Stricture and pain resolution were investigated. Other outcomes included technical success, stent migration, stricture recurrence and need for repeated stent placement. Pancreatitis, severe abdominal pain requiring stent removal and de-novo stricture were recorded as complications.

Results Nineteen studies were identified, which included a total of 300 patients. C-SEMSs showed a pooled stricture resolution rate of 91 % [95 % confidence interval (CI), 85 %–96 %] and a pooled pain resolution rate of 92 % (95 % CI, 85 %–98 %). The pooled proportion for stricture recurrence was equal to 6 % (95 % CI, 1 %–14 %), while stent migration occurred in 33 of 300 patients, the pooled proportion being 7 % (95 % CI 1 %–15 %). The pooled mean stent duration was 133 days (95 % CI, 100–166 days). The most common complication was pancreatitis (3 %, 95 % CI 0 %–8 %), while de-novo stricture pooled proportion was 2 % (95 % CI, 0 %–5 %).

Conclusions C-SEMSs are effective and safe in the treatment of MPDS. However, there is a significant need for further high-quality, well-designed studies to produce evidence-based data on short and long-term efficacy, safety, costs of C-SEMSs, and also optimal stent duration.

Publication History

Received: 05 December 2021

Accepted after revision: 14 June 2022

Accepted Manuscript online:
21 June 2022

Article published online:
14 September 2022

• 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 Eur Gastroenterol J 2017; 5: 153-199
• 2 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
• 3 Cahen DL, Gouma DJ, Nio Y. et al. Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis. N Engl J Med 2007; 356: 676-684
• 4 Ponchon T, Bory RM, Hedelius F. et al. Endoscopic stenting for pain relief in chronic pancreatitis: Results of a standardized protocol. Gastrointest Endosc 1995; 42: 452-456
• 5 Cremer M, Devière J, Delhaye M. et al. Stenting in severe chronic pancreatitis: results of medium-term follow-up in seventy-six patients. Endoscopy 1991; 23: 171-176
• 6 Ishihara T, Yamaguchi T, Seza K. et al. Efficacy of s-type stents for the treatment of the main pancreatic duct stricture in patients with chronic pancreatitis. Scand J Gastroenterol 2006; 41: 744-750
• 7 Topazian M, Aslanian H, Andersen D. Outcome following endoscopic stenting of pancreatic duct strictures in chronic pancreatitis. J Clin Gastroenterol 2005; 39: 908-911
• 8 Jafri M, Sachdev A, Sadiq J. et al. Efficacy of endotherapy in the treatment of pain associated with chronic pancreatitis: a systematic review and meta-analysis. J Pancreas 2017; 18: 125-132
• 9 Costamagna G, Bulajic M, Tringali A. et al. Multiple stenting of refractory pancreatic duct strictures in severe chronic pancreatitis: long-term results. Endoscopy 2006; 38: 254-259
• 10 Tringali A, Bove V, Vadalà di Prampero SF. et al. Long-term follow-up after multiple plastic stenting for refractory pancreatic duct strictures in chronic pancreatitis. Endoscopy 2019; 51: 930-935
• 11 Seza K, Yamaguchi T, Ishihara T. et al. A long-term controlled trial of endoscopic pancreatic stenting for treatment of main pancreatic duct stricture in chronic pancreatitis. Hepatogastroenterology 2011; 58: 2128-2131
• 12 Shen Y, Liu M, Chen M. et al. Covered metal stent or multiple plastic stents for refractory pancreatic ductal strictures in chronic pancreatitis: A systematic review. Pancreatology 2014; 14: 87-90
• 13 Li TT, Song SL, Xiao LN. et al. Efficacy of fully covered self-expandable metal stents for the management of pancreatic duct strictures in chronic pancreatitis: A systematic review and meta-analysis. J Gastroenterol Hepatol 2020; 35: 1099-1106
• 14 Moher D, Liberati A, Tetzlaff J. et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009; 339: b2535
• 15 DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986; 7: 177-188
• 16 Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002; 21: 1539-1558
• 17 Egger M, Davey Smith G, Schneider M. et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997; 315: 629-634
• 18 Cho JH, Kim EJ, Kim KO. et al. Long-term outcomes of fully covered self-expandable metal stents in benign pancreatic ductal stricture of chronic pancreatitis. Pancreas 2019; 48: 1414
• 19 Patel A, Ukabam OC, Atluri S. et al. The use of fully covered metal stents in the management of benign refractory pancreatic ductal strictures. Gastrointest Endosc 2017; 85: AB236
• 20 Jain RP, Dharamsi S, Basava G. et al. Long term outcomes of fully covered self-expanding metal stents for refractory pancreatic duct strictures due to chronic pancreatitis-a single center experience from India. J Gastroenterol Hepatol 2019; 34: 218
• 21 Sangwaiya A, Butt MA, Rajaratnam R. et al. Covered metal stent placement using Santorini’s duct (minor papilla) for pain management in chronic calcific pancreatitis – feasibility and safety. Gastrointest Endosc 2015; 81: AB404
• 22 Shen Y-H, Li Y-H, Wang L. et al. Placement of a fully covered self-expandable metal stent for refractory chronic pancreatitis: A preliminary study. J Dig Dis 2019; 20: 5
• 23 Traini M, Mariani A, Petrone MC. et al. Fully covered self-expandable metal stents (FC-SEMS) in the treatment of main pancreatic duct (MPD) strictures due to chronic pancreatitis (CP): A case series. Dig Liver Dis 2018; 50: e146
• 24 Giacino C, Grandval P, Laugier R. Fully covered self-expanding metal stents for refractory pancreatic duct strictures in chronic pancreatitis. Endoscopy 2012; 44: 874-877
• 25 Sauer B, Talreja J, Ellen K. et al. Temporary placement of a fully covered self-expandable metal stent in the pancreatic duct for management of symptomatic refractory chronic pancreatitis: preliminary data (with videos). Gastrointest Endosc 2008; 68: 1173-1178
• 26 Park DH, Kim MH, Moon SH. et al. Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video). Gastrointest Endosc 2008; 68: 1182-1189
• 27 Moon S-H, Kim M-H, Park DH. et al. Modified fully covered self-expandable metal stents with antimigration features for benign pancreatic-duct strictures in advanced chronic pancreatitis, with a focus on the safety profile and reducing migration. Gastrointest Endosc 2010; 72: 86-91
• 28 Tringali A, Vadalà di Prampero SF, Landi R. et al. Fully covered self-expandable metal stents to dilate persistent pancreatic strictures in chronic pancreatitis: long-term follow-up from a prospective study. Gastrointest Endosc 2018; 88: 939-946
• 29 Sharaiha RZ, Novikov A, Weaver K. et al. Fully covered self-expanding metal stents for refractory pancreatic duct strictures in symptomatic chronic pancreatitis, US experience. Endosc Int Open 2019; 7: E1419-E1423
• 30 Korpela T, Udd M, Lindström O. et al. Fully covered self-expanding metal stents for benign refractory pancreatic duct strictures in chronic pancreatitis. Scand J Gastroenterol 2019; 54: 365-370
• 31 Lee YN, Moon JH, Park JK. et al. Preliminary study of a modified, nonflared, short, fully covered metal stent for refractory benign pancreatic duct strictures (with videos). Gastrointest Endosc 2020; 91: 826-833
• 32 Ogura T, Onda S, Takagi W. et al. Placement of a 6 mm, fully covered metal stent for main pancreatic head duct stricture due to chronic pancreatitis: A pilot study (with video). Therap Adv Gastroenterol 2016; 9: 722-728
• 33 Yamada T, Ogura T, Okuda A. et al. Pilot Study of Dumbbell-Type Covered Self-Expandable Metal Stent Deployment for Benign Pancreatic Duct Stricture (with Videos). J Gastrointest Surg 2018; 22: 2194-2200
• 34 Oh D, Lee JH, Song TJ. et al. Long-term outcomes of 6-mm diameter fully covered self-expandable metal stents in benign refractory pancreatic ductal stricture. Dig Endosc 2018; 30: 508-515
• 35 Okushima K, Yoshino J, Inui K. et al. Short-term metal stenting for treatment of main pancreatic duct strictures associated with chronic pancreatitis. Dig Endosc 2005; 17: 230-234
• 36 Matsubara S, Sasahira N, Isayama H. et al. Prospective pilot study of fully covered self-expandable metal stents for refractory benign pancreatic duct strictures: long-term outcomes. Endosc Int Open 2016; 04: E1227-E1227
• 37 Tammaro S, Caruso R, Pallone F. et al. Post-endoscopic retrograde cholangio-pancreatography pancreatitis: is time for a new preventive approach?. World J Gastroenterol 2012; 18: 4635-4638
• 38 Puig I, Calvet X, Baylina M. et al. How and when should NSAIDs be used for preventing post-ERCP pancreatitis?. A systematic review and meta-analysis. PLoS One 2014; 9: e92922
• 39 Wong L-L, Tsai H-H. Prevention of post-ERCP pancreatitis. World J Gastrointest Pathophysiol 2014; 5: 1-10
• 40 Haapamäki C, Kylänpää L, Udd M. et al. Randomized multicenter study of multiple plastic stents vscovered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy 2015; 47: 605-610
• 41 Cahen DL, van der Merwe SW, Laleman W. et al. A biodegradable non-covered self-expandable stent to treat pancreatic duct strictures in chronic pancreatitis: a proof of principle. Gastrointest Endosc 2018; 87: 486-491