Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial

Camilla Nøjgaard; Mads Hornum; Margarita Elkjaer; Claes Hjalmarsson; Laurent Heyries; Truls Hauge; Kåre Bakkevold; Per Kragh Andersen; Peter Matzen; European Post-ERCP Pancreatitis Preventing Study Group; Camilla Nøjgaard; Mads Hornum; Margarita Elkjaer; Claes Hjalmarsson; Laurent Heyries; Truls Hauge; Kåre Bakkevold; Per Kragh Andersen; Peter Matzen; NN NN

doi:10.1016/j.gie.2008.11.042

Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial

Camilla Nøjgaard, Mads Hornum, Margarita Elkjaer, Claes Hjalmarsson, Laurent Heyries, Truls Hauge, Kåre Bakkevold, Per Kragh Andersen, Peter Matzen, European Post-ERCP Pancreatitis Preventing Study Group, Camilla Nøjgaard, Mads Hornum, Margarita Elkjaer, Claes Hjalmarsson, Laurent Heyries, Truls Hauge, Kåre Bakkevold, Per Kragh Andersen, Peter Matzen, NN NN

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

31 Citationer (Scopus)

Abstract

Udgivelsesdato: 2009-May

Originalsprog	Engelsk
Tidsskrift	Gastrointestinal Endoscopy
Vol/bind	69
Udgave nummer	6
Sider (fra-til)	e31-7
ISSN	0016-5107
DOI	https://doi.org/10.1016/j.gie.2008.11.042 https://doi.org/10.1016/j.gie.2008.11.042
Status	Udgivet - 2009

Bibliografisk note

Keywords: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Cholangiopancreatography, Endoscopic Retrograde; Double-Blind Method; Female; Humans; Male; Middle Aged; Nitroglycerin; Pancreatitis, Acute Necrotizing; Risk; Vasodilator Agents; Young Adult

Adgang til dokumentet

Citationsformater

Nøjgaard, C., Hornum, M., Elkjaer, M., Hjalmarsson, C., Heyries, L., Hauge, T., Bakkevold, K., Andersen, P. K., Matzen, P., European Post-ERCP Pancreatitis Preventing Study Group, Nøjgaard, C., Hornum, M., Elkjaer, M., Hjalmarsson, C., Heyries, L., Hauge, T., Bakkevold, K., Andersen, P. K., Matzen, P., & NN, NN. (2009). Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial. Gastrointestinal Endoscopy, 69(6), e31-7. https://doi.org/10.1016/j.gie.2008.11.042, https://doi.org/10.1016/j.gie.2008.11.042

Nøjgaard, C, Hornum, M, Elkjaer, M, Hjalmarsson, C, Heyries, L, Hauge, T, Bakkevold, K, Andersen, PK, Matzen, P, European Post-ERCP Pancreatitis Preventing Study Group, Nøjgaard, C, Hornum, M, Elkjaer, M, Hjalmarsson, C, Heyries, L, Hauge, T, Bakkevold, K, Andersen, PK, Matzen, P & NN, NN 2009, 'Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial', Gastrointestinal Endoscopy, bind 69, nr. 6, s. e31-7. https://doi.org/10.1016/j.gie.2008.11.042, https://doi.org/10.1016/j.gie.2008.11.042

@article{50490d60872811de8bc9000ea68e967b,

title = "Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial",

abstract = "OBJECTIVE: Acute pancreatitis is the most dreaded complication of ERCP. Two studies have shown a significant effect of glyceryl nitrate (GN) in preventing post-ERCP pancreatitis (PEP). We wanted to evaluate this promising effect in a larger study with a realistically precalculated incidence of PEP. DESIGN/PATIENTS: A randomized, double-blind, placebo-controlled multicenter study including patients from 14 European centers was performed. A total of 820 patients were entered; 806 were randomized. INTERVENTION: The active drug was transdermal GN (Discotrine/Minitran, 3M Pharma) 15 mg/24 hours; placebo (PL) was an identical-looking patch applied before ERCP. A total of 401 patients received GN; 405 received PL. RESULTS: Forty-seven patients had PEP (5.8%), 18 (4.5%) in the GN group and 29 (7.1%) in the PL group. The relative risk reduction of PEP in the GN group of 36% (95% CI, 11%-65%) compared with the PL group was not statistically significant (P = .11). Thirteen had mild pancreatitis (4 in the GN group, 9 in the PL group), 26 had moderate pancreatitis (9 in the GN group, 17 in the PL group), and 8 had severe pancreatitis (5 in the GN group, 3 in the PL group). Headache (P < .001) and hypotension (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure. CONCLUSIONS: The trial showed no statistically significant preventive effect of GN on PEP. Because of a considerable risk of a type II error, an effect of GN may have been overlooked. (ClinicalTrials.gov ID: NCT00121901.).",

author = "Camilla N{\o}jgaard and Mads Hornum and Margarita Elkjaer and Claes Hjalmarsson and Laurent Heyries and Truls Hauge and K{\aa}re Bakkevold and Andersen, {Per Kragh} and Peter Matzen and {European Post-ERCP Pancreatitis Preventing Study Group} and Camilla N{\o}jgaard and Mads Hornum and Margarita Elkjaer and Claes Hjalmarsson and Laurent Heyries and Truls Hauge and K{\aa}re Bakkevold and Andersen, {Per Kragh} and Peter Matzen and NN NN",

note = "Keywords: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Cholangiopancreatography, Endoscopic Retrograde; Double-Blind Method; Female; Humans; Male; Middle Aged; Nitroglycerin; Pancreatitis, Acute Necrotizing; Risk; Vasodilator Agents; Young Adult",

year = "2009",

doi = "10.1016/j.gie.2008.11.042",

language = "English",

volume = "69",

pages = "e31--7",

journal = "Gastrointestinal Endoscopy",

issn = "0016-5107",

publisher = "Mosby Inc.",

number = "6",

}

TY - JOUR

T1 - Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial

AU - Nøjgaard, Camilla

AU - Hornum, Mads

AU - Elkjaer, Margarita

AU - Hjalmarsson, Claes

AU - Heyries, Laurent

AU - Hauge, Truls

AU - Bakkevold, Kåre

AU - Andersen, Per Kragh

AU - Matzen, Peter

AU - European Post-ERCP Pancreatitis Preventing Study Group

AU - Nøjgaard, Camilla

AU - Hornum, Mads

AU - Elkjaer, Margarita

AU - Hjalmarsson, Claes

AU - Heyries, Laurent

AU - Hauge, Truls

AU - Bakkevold, Kåre

AU - Andersen, Per Kragh

AU - Matzen, Peter

AU - NN, NN

N1 - Keywords: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Cholangiopancreatography, Endoscopic Retrograde; Double-Blind Method; Female; Humans; Male; Middle Aged; Nitroglycerin; Pancreatitis, Acute Necrotizing; Risk; Vasodilator Agents; Young Adult

PY - 2009

Y1 - 2009

N2 - OBJECTIVE: Acute pancreatitis is the most dreaded complication of ERCP. Two studies have shown a significant effect of glyceryl nitrate (GN) in preventing post-ERCP pancreatitis (PEP). We wanted to evaluate this promising effect in a larger study with a realistically precalculated incidence of PEP. DESIGN/PATIENTS: A randomized, double-blind, placebo-controlled multicenter study including patients from 14 European centers was performed. A total of 820 patients were entered; 806 were randomized. INTERVENTION: The active drug was transdermal GN (Discotrine/Minitran, 3M Pharma) 15 mg/24 hours; placebo (PL) was an identical-looking patch applied before ERCP. A total of 401 patients received GN; 405 received PL. RESULTS: Forty-seven patients had PEP (5.8%), 18 (4.5%) in the GN group and 29 (7.1%) in the PL group. The relative risk reduction of PEP in the GN group of 36% (95% CI, 11%-65%) compared with the PL group was not statistically significant (P = .11). Thirteen had mild pancreatitis (4 in the GN group, 9 in the PL group), 26 had moderate pancreatitis (9 in the GN group, 17 in the PL group), and 8 had severe pancreatitis (5 in the GN group, 3 in the PL group). Headache (P < .001) and hypotension (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure. CONCLUSIONS: The trial showed no statistically significant preventive effect of GN on PEP. Because of a considerable risk of a type II error, an effect of GN may have been overlooked. (ClinicalTrials.gov ID: NCT00121901.).

AB - OBJECTIVE: Acute pancreatitis is the most dreaded complication of ERCP. Two studies have shown a significant effect of glyceryl nitrate (GN) in preventing post-ERCP pancreatitis (PEP). We wanted to evaluate this promising effect in a larger study with a realistically precalculated incidence of PEP. DESIGN/PATIENTS: A randomized, double-blind, placebo-controlled multicenter study including patients from 14 European centers was performed. A total of 820 patients were entered; 806 were randomized. INTERVENTION: The active drug was transdermal GN (Discotrine/Minitran, 3M Pharma) 15 mg/24 hours; placebo (PL) was an identical-looking patch applied before ERCP. A total of 401 patients received GN; 405 received PL. RESULTS: Forty-seven patients had PEP (5.8%), 18 (4.5%) in the GN group and 29 (7.1%) in the PL group. The relative risk reduction of PEP in the GN group of 36% (95% CI, 11%-65%) compared with the PL group was not statistically significant (P = .11). Thirteen had mild pancreatitis (4 in the GN group, 9 in the PL group), 26 had moderate pancreatitis (9 in the GN group, 17 in the PL group), and 8 had severe pancreatitis (5 in the GN group, 3 in the PL group). Headache (P < .001) and hypotension (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure. CONCLUSIONS: The trial showed no statistically significant preventive effect of GN on PEP. Because of a considerable risk of a type II error, an effect of GN may have been overlooked. (ClinicalTrials.gov ID: NCT00121901.).

U2 - 10.1016/j.gie.2008.11.042

DO - 10.1016/j.gie.2008.11.042

M3 - Journal article

C2 - 19410035

SN - 0016-5107

VL - 69

SP - e31-7

JO - Gastrointestinal Endoscopy

JF - Gastrointestinal Endoscopy

IS - 6

ER -