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

26 Citations (Scopus)

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.).

Original language	English
Journal	Gastrointestinal Endoscopy
Volume	69
Issue number	6
Pages (from-to)	e31-7
ISSN	0016-5107
DOIs	https://doi.org/10.1016/j.gie.2008.11.042 https://doi.org/10.1016/j.gie.2008.11.042
Publication status	Published - 2009

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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, vol. 69, no. 6, pp. 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 -

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

Abstract

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