A prospective, randomized, placebo-controlled trial of transdermal glyceryl trinitrate in ERCP: effects on technical success and post-ERCP pancreatitis.
BACKGROUND
Despite the recent improvement in techniques and patient selection, post-ERCP pancreatitis remains the most frequent and dreaded complication of ERCP. Recent studies suggest that pretreatment with glyceryl trinitrate (GTN) may prevent post-ERCP pancreatitis and improve cannulation success.


OBJECTIVE
To evaluate the effect of transdermal GTN on ERCP cannulation success and post-ERCP pancreatitis.


METHODS
Prospective, double-blind, placebo-controlled trial.


METHODS
Tertiary referral university hospital.


METHODS
A total of 318 patients (mean age 62 years, 61% women) were randomized to either active (n = 155) or placebo (n = 163) arms.


METHODS
Active patch (GTN) versus placebo patch.


METHODS
Cannulation time and success. Post-ERCP pancreatitis rates.


RESULTS
There was no significant difference between the active or placebo arms for the following: successful initial cannulation (96.8% vs 98.8%), deep cannulation (96.1% vs 98.8%), time to successful cannulation, use of guidewire (27% vs 25%) or needle knife (13% vs 13%), and post-ERCP pancreatitis (7.4% of placebo patients and 7.7% active patients). Multivariate analysis identified women, younger patients, pancreatogram, number of attempts on papilla, and poor pancreatic-duct emptying after opacification as risk factors for post-ERCP pancreatitis. Transdermal GTN did not reduce post-ERCP pancreatitis in any of the identified high-risk groups.


CONCLUSIONS
Transdermal GTN did not improve the rate of success in ERCP cannulation or prevent post-ERCP pancreatitis in either average or high-risk patient groups.
Kaffes
Arthur John
AJ
Department of Gastroenterology and Hepatology, Westmead Hospital, Westmead, Australia.
Bourke
Michael John
MJ
Ding
Stephen
S
Alrubaie
Ahmad
A
Kwan
Vu
V
Williams
Stephen John
SJ
D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization / Q000009:adverse effects*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D005996:Nitroglycerin / Q000008:administration & dosage / Q000627:therapeutic use*; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011300:Preoperative Care; D011446:Prospective Studies; D012307:Risk Factors; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*
D014665:Vasodilator Agents; D005996:Nitroglycerin