Reducing the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-Fr pancreatic plastic stents placed with common-type guidewires: Results from a prospective multinational registry

the Pancreatic Stenting Registry Group

doi:10.1111/den.13311

Reducing the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-Fr pancreatic plastic stents placed with common-type guidewires: Results from a prospective multinational registry

the Pancreatic Stenting Registry Group

Medicine - Gastro, Hepatology, Nutrition Division

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

Background and Aim: Pancreatic plastic stents (PPS) can reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Prospective multicenter documentation of PEP rate after PPS placement is scarce. A new 4-Fr stent designed to be deployed over a 0.035-inch guidewire was used to assess the effectiveness of PEP prophylaxis. Methods: High-PEP-risk patients received a 4-Fr PPS for primary or secondary prophylaxis at seven centers in four countries. Patients were followed until spontaneous PPS migration, endoscopic stent removal, or for 4 months, whichever came first. Main outcome was PEP rate. Results: One hundred six (106) patients received PPS for PEP prophylaxis [61 (58%) primary, 45 (42%) secondary prophylaxis]. Median age was 54 years. Eighty-one (76%) PPS were placed using a 0.035-inch guidewire. By investigator choice 99 (93%) stents were single pigtail. Median stent length was 8 cm (range 3–12 cm). Technical success achieved in 100% of cases. Two patients in the primary prophylaxis group (3%, 95% CI 0.4–11%) experienced mild/moderate PEP. Seventy-eight PPS available for analysis underwent spontaneous migration after a median of 29 days. There were no reports of stent-induced ductal trauma. Post-hoc analysis of migration rate by PPS length showed no statistically significant trend. Conclusions: Among high-risk patients in the primary prophylaxis group, observed rates of PEP are low (3%, 95% CI 0.4–11%) with the use of prophylactic 4-Fr pancreatic duct stents compatible with a 0.035-inch guidewire. This low rate is not unequivocally due to the prophylactic stent.

Original language	English (US)
Pages (from-to)	299-306
Number of pages	8
Journal	Digestive Endoscopy
Volume	31
Issue number	3
DOIs	https://doi.org/10.1111/den.13311
State	Published - May 2019

Bibliographical note

Funding Information:
The following individuals contributed in meaningful ways to the research presented in this paper: The Pancreatic Stenting Registry Group membership consists of Nadav Sahar; Andrew Ross; Sundeep Lakhtakia; Gregory Coté; Horst Neuhaus; Marco J. Bruno; Oleh Haluszka; Seng-Ian Gan (Virginia Mason Medical Center, Seattle, USA); Michael Gluck (Virginia Mason Medical Center, Seattle, USA); Shayan Irani (Virginia Mason Medical Center, Seattle, USA); Richard Kozarek; Michael Larsen (Virginia Mason Medical Center, Seattle, USA); Mohan Ramchandani; D. Nageshwar Reddy (Asian Institute of Gastroenterology, Hyderabad, India); Nicole Balasus (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Philipp Bender (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Torsten Beyna; Christian Gerges (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Jennis Kandler (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Andre Ragheb (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Paul Didden (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); M.J.A.L. Grubben (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); Arjun Koch (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); Jan Poley; Jennifer Maranki; Kaveh Sharzehi (Temple University Health System, Philadelphia, USA); Martin Freeman; Prashant Kedia; and Paul Tarnasky. Christine Fazio, Matthew Rousseau and Joyce Peetermans, all employees of Boston Scientific Corporation, contributed to study design, planning and conduct, statistical analysis, and critical review of the manuscript.

Funding Information:
A.R. IS A consultant for Boston Scientific. G.A.C. is a consultant for Boston Scientific and Olympus Corporation. H.N. receives research support from Boston Scientific, Cook Medical, ERBE, and CDx Diagnostics, and he is a consultant for Boston Scientific, Cook Medical, ERBE, and Olympus. H.N. also receives speaker’s fees from Boston Scientific, Cook Medical, ERBE, Olympus, the Falk Foundation, Fujifilm, and Medtronic. M.J.B. is a consultant for and receives research grants from Boston Scientific, Cook Medical, 3M, and Pentax Medical. R.K. receives research support from Boston Scientific and book royalties from Wiley-Blackwell, Springer, and Elsevier. T.B. is a consultant for Boston Scientific. J.W.P. is a consultant for Boston Scientific, Cook Endoscopy, and Pentax Medical. M.F. is a consultant for Boston Scientific and receives speaker’s fees from Cook Endoscopy. P.K. is a consultant for Boston Scientific. P.T. is a consultant for Boston Scientific. All other authors declare no conflicts of interest with respect to this work. This registry was sponsored by Boston Scientific Corporation and registered under number NCT02262845 in the USA and CTRI/2015/09/006194 in India.

Publisher Copyright:
© 2018 Japan Gastroenterological Endoscopy Society

Keywords

guidewire
pancreatography
plastic pancreatic stent
post-ERCP pancreatitis
stent migration

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Reducing the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-Fr pancreatic plastic stents placed with common-type guidewires: Results from a prospective multinational registry. / the Pancreatic Stenting Registry Group.
In: Digestive Endoscopy, Vol. 31, No. 3, 05.2019, p. 299-306.

Research output: Contribution to journal › Article › peer-review

@article{f062742f465e4c449bb594cebd893af7,

title = "Reducing the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-Fr pancreatic plastic stents placed with common-type guidewires: Results from a prospective multinational registry",

abstract = "Background and Aim: Pancreatic plastic stents (PPS) can reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Prospective multicenter documentation of PEP rate after PPS placement is scarce. A new 4-Fr stent designed to be deployed over a 0.035-inch guidewire was used to assess the effectiveness of PEP prophylaxis. Methods: High-PEP-risk patients received a 4-Fr PPS for primary or secondary prophylaxis at seven centers in four countries. Patients were followed until spontaneous PPS migration, endoscopic stent removal, or for 4 months, whichever came first. Main outcome was PEP rate. Results: One hundred six (106) patients received PPS for PEP prophylaxis [61 (58%) primary, 45 (42%) secondary prophylaxis]. Median age was 54 years. Eighty-one (76%) PPS were placed using a 0.035-inch guidewire. By investigator choice 99 (93%) stents were single pigtail. Median stent length was 8 cm (range 3–12 cm). Technical success achieved in 100% of cases. Two patients in the primary prophylaxis group (3%, 95% CI 0.4–11%) experienced mild/moderate PEP. Seventy-eight PPS available for analysis underwent spontaneous migration after a median of 29 days. There were no reports of stent-induced ductal trauma. Post-hoc analysis of migration rate by PPS length showed no statistically significant trend. Conclusions: Among high-risk patients in the primary prophylaxis group, observed rates of PEP are low (3%, 95% CI 0.4–11%) with the use of prophylactic 4-Fr pancreatic duct stents compatible with a 0.035-inch guidewire. This low rate is not unequivocally due to the prophylactic stent.",

keywords = "guidewire, pancreatography, plastic pancreatic stent, post-ERCP pancreatitis, stent migration",

author = "{the Pancreatic Stenting Registry Group} and Nadav Sahar and Andrew Ross and Sundeep Lakhtakia and Cot{\'e}, {Gregory A.} and Horst Neuhaus and Bruno, {Marco J.} and Oleh Haluszka and Richard Kozarek and Mohan Ramchandani and Torsten Beyna and Poley, {Jan W.} and Jennifer Maranki and Martin Freeman and Prashant Kedia and Paul Tarnasky",

note = "Funding Information: The following individuals contributed in meaningful ways to the research presented in this paper: The Pancreatic Stenting Registry Group membership consists of Nadav Sahar; Andrew Ross; Sundeep Lakhtakia; Gregory Cot{\'e}; Horst Neuhaus; Marco J. Bruno; Oleh Haluszka; Seng-Ian Gan (Virginia Mason Medical Center, Seattle, USA); Michael Gluck (Virginia Mason Medical Center, Seattle, USA); Shayan Irani (Virginia Mason Medical Center, Seattle, USA); Richard Kozarek; Michael Larsen (Virginia Mason Medical Center, Seattle, USA); Mohan Ramchandani; D. Nageshwar Reddy (Asian Institute of Gastroenterology, Hyderabad, India); Nicole Balasus (Evangelisches Krankenhaus D{\"u}sseldorf, D{\"u}sseldorf, Germany); Philipp Bender (Evangelisches Krankenhaus D{\"u}sseldorf, D{\"u}sseldorf, Germany); Torsten Beyna; Christian Gerges (Evangelisches Krankenhaus D{\"u}sseldorf, D{\"u}sseldorf, Germany); Jennis Kandler (Evangelisches Krankenhaus D{\"u}sseldorf, D{\"u}sseldorf, Germany); Andre Ragheb (Evangelisches Krankenhaus D{\"u}sseldorf, D{\"u}sseldorf, Germany); Paul Didden (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); M.J.A.L. Grubben (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); Arjun Koch (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); Jan Poley; Jennifer Maranki; Kaveh Sharzehi (Temple University Health System, Philadelphia, USA); Martin Freeman; Prashant Kedia; and Paul Tarnasky. Christine Fazio, Matthew Rousseau and Joyce Peetermans, all employees of Boston Scientific Corporation, contributed to study design, planning and conduct, statistical analysis, and critical review of the manuscript. Funding Information: A.R. IS A consultant for Boston Scientific. G.A.C. is a consultant for Boston Scientific and Olympus Corporation. H.N. receives research support from Boston Scientific, Cook Medical, ERBE, and CDx Diagnostics, and he is a consultant for Boston Scientific, Cook Medical, ERBE, and Olympus. H.N. also receives speaker{\textquoteright}s fees from Boston Scientific, Cook Medical, ERBE, Olympus, the Falk Foundation, Fujifilm, and Medtronic. M.J.B. is a consultant for and receives research grants from Boston Scientific, Cook Medical, 3M, and Pentax Medical. R.K. receives research support from Boston Scientific and book royalties from Wiley-Blackwell, Springer, and Elsevier. T.B. is a consultant for Boston Scientific. J.W.P. is a consultant for Boston Scientific, Cook Endoscopy, and Pentax Medical. M.F. is a consultant for Boston Scientific and receives speaker{\textquoteright}s fees from Cook Endoscopy. P.K. is a consultant for Boston Scientific. P.T. is a consultant for Boston Scientific. All other authors declare no conflicts of interest with respect to this work. This registry was sponsored by Boston Scientific Corporation and registered under number NCT02262845 in the USA and CTRI/2015/09/006194 in India. Publisher Copyright: {\textcopyright} 2018 Japan Gastroenterological Endoscopy Society",

year = "2019",

month = may,

doi = "10.1111/den.13311",

language = "English (US)",

volume = "31",

pages = "299--306",

journal = "Digestive Endoscopy",

issn = "0915-5635",

publisher = "Wiley-Blackwell",

number = "3",

}

TY - JOUR

T1 - Reducing the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-Fr pancreatic plastic stents placed with common-type guidewires

T2 - Results from a prospective multinational registry

AU - the Pancreatic Stenting Registry Group

AU - Sahar, Nadav

AU - Ross, Andrew

AU - Lakhtakia, Sundeep

AU - Coté, Gregory A.

AU - Neuhaus, Horst

AU - Bruno, Marco J.

AU - Haluszka, Oleh

AU - Kozarek, Richard

AU - Ramchandani, Mohan

AU - Beyna, Torsten

AU - Poley, Jan W.

AU - Maranki, Jennifer

AU - Freeman, Martin

AU - Kedia, Prashant

AU - Tarnasky, Paul

N1 - Funding Information: The following individuals contributed in meaningful ways to the research presented in this paper: The Pancreatic Stenting Registry Group membership consists of Nadav Sahar; Andrew Ross; Sundeep Lakhtakia; Gregory Coté; Horst Neuhaus; Marco J. Bruno; Oleh Haluszka; Seng-Ian Gan (Virginia Mason Medical Center, Seattle, USA); Michael Gluck (Virginia Mason Medical Center, Seattle, USA); Shayan Irani (Virginia Mason Medical Center, Seattle, USA); Richard Kozarek; Michael Larsen (Virginia Mason Medical Center, Seattle, USA); Mohan Ramchandani; D. Nageshwar Reddy (Asian Institute of Gastroenterology, Hyderabad, India); Nicole Balasus (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Philipp Bender (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Torsten Beyna; Christian Gerges (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Jennis Kandler (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Andre Ragheb (Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany); Paul Didden (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); M.J.A.L. Grubben (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); Arjun Koch (Erasmus MC, University Medical Center, Rotterdam, The Netherlands); Jan Poley; Jennifer Maranki; Kaveh Sharzehi (Temple University Health System, Philadelphia, USA); Martin Freeman; Prashant Kedia; and Paul Tarnasky. Christine Fazio, Matthew Rousseau and Joyce Peetermans, all employees of Boston Scientific Corporation, contributed to study design, planning and conduct, statistical analysis, and critical review of the manuscript. Funding Information: A.R. IS A consultant for Boston Scientific. G.A.C. is a consultant for Boston Scientific and Olympus Corporation. H.N. receives research support from Boston Scientific, Cook Medical, ERBE, and CDx Diagnostics, and he is a consultant for Boston Scientific, Cook Medical, ERBE, and Olympus. H.N. also receives speaker’s fees from Boston Scientific, Cook Medical, ERBE, Olympus, the Falk Foundation, Fujifilm, and Medtronic. M.J.B. is a consultant for and receives research grants from Boston Scientific, Cook Medical, 3M, and Pentax Medical. R.K. receives research support from Boston Scientific and book royalties from Wiley-Blackwell, Springer, and Elsevier. T.B. is a consultant for Boston Scientific. J.W.P. is a consultant for Boston Scientific, Cook Endoscopy, and Pentax Medical. M.F. is a consultant for Boston Scientific and receives speaker’s fees from Cook Endoscopy. P.K. is a consultant for Boston Scientific. P.T. is a consultant for Boston Scientific. All other authors declare no conflicts of interest with respect to this work. This registry was sponsored by Boston Scientific Corporation and registered under number NCT02262845 in the USA and CTRI/2015/09/006194 in India. Publisher Copyright: © 2018 Japan Gastroenterological Endoscopy Society

PY - 2019/5

Y1 - 2019/5

N2 - Background and Aim: Pancreatic plastic stents (PPS) can reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Prospective multicenter documentation of PEP rate after PPS placement is scarce. A new 4-Fr stent designed to be deployed over a 0.035-inch guidewire was used to assess the effectiveness of PEP prophylaxis. Methods: High-PEP-risk patients received a 4-Fr PPS for primary or secondary prophylaxis at seven centers in four countries. Patients were followed until spontaneous PPS migration, endoscopic stent removal, or for 4 months, whichever came first. Main outcome was PEP rate. Results: One hundred six (106) patients received PPS for PEP prophylaxis [61 (58%) primary, 45 (42%) secondary prophylaxis]. Median age was 54 years. Eighty-one (76%) PPS were placed using a 0.035-inch guidewire. By investigator choice 99 (93%) stents were single pigtail. Median stent length was 8 cm (range 3–12 cm). Technical success achieved in 100% of cases. Two patients in the primary prophylaxis group (3%, 95% CI 0.4–11%) experienced mild/moderate PEP. Seventy-eight PPS available for analysis underwent spontaneous migration after a median of 29 days. There were no reports of stent-induced ductal trauma. Post-hoc analysis of migration rate by PPS length showed no statistically significant trend. Conclusions: Among high-risk patients in the primary prophylaxis group, observed rates of PEP are low (3%, 95% CI 0.4–11%) with the use of prophylactic 4-Fr pancreatic duct stents compatible with a 0.035-inch guidewire. This low rate is not unequivocally due to the prophylactic stent.

AB - Background and Aim: Pancreatic plastic stents (PPS) can reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Prospective multicenter documentation of PEP rate after PPS placement is scarce. A new 4-Fr stent designed to be deployed over a 0.035-inch guidewire was used to assess the effectiveness of PEP prophylaxis. Methods: High-PEP-risk patients received a 4-Fr PPS for primary or secondary prophylaxis at seven centers in four countries. Patients were followed until spontaneous PPS migration, endoscopic stent removal, or for 4 months, whichever came first. Main outcome was PEP rate. Results: One hundred six (106) patients received PPS for PEP prophylaxis [61 (58%) primary, 45 (42%) secondary prophylaxis]. Median age was 54 years. Eighty-one (76%) PPS were placed using a 0.035-inch guidewire. By investigator choice 99 (93%) stents were single pigtail. Median stent length was 8 cm (range 3–12 cm). Technical success achieved in 100% of cases. Two patients in the primary prophylaxis group (3%, 95% CI 0.4–11%) experienced mild/moderate PEP. Seventy-eight PPS available for analysis underwent spontaneous migration after a median of 29 days. There were no reports of stent-induced ductal trauma. Post-hoc analysis of migration rate by PPS length showed no statistically significant trend. Conclusions: Among high-risk patients in the primary prophylaxis group, observed rates of PEP are low (3%, 95% CI 0.4–11%) with the use of prophylactic 4-Fr pancreatic duct stents compatible with a 0.035-inch guidewire. This low rate is not unequivocally due to the prophylactic stent.

KW - guidewire

KW - pancreatography

KW - plastic pancreatic stent

KW - post-ERCP pancreatitis

KW - stent migration

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U2 - 10.1111/den.13311

DO - 10.1111/den.13311

M3 - Article

C2 - 30887733

AN - SCOPUS:85060648896

SN - 0915-5635

VL - 31

SP - 299

EP - 306

JO - Digestive Endoscopy

JF - Digestive Endoscopy

IS - 3

ER -

Reducing the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-Fr pancreatic plastic stents placed with common-type guidewires: Results from a prospective multinational registry

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