Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate.
OBJECTIVE
It still is debated whether post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be prevented by administering either somatostatin or gabexate mesylate. The aim of the study is to assess the efficacy of a 6.5-hour infusion of somatostatin or gabexate mesylate in preventing ERCP-related complications.


METHODS
In a double-blind multicenter trial, 1127 patients undergoing ERCP were randomly assigned to intravenous administration of somatostatin (750 microg; n = 351), gabexate mesylate (500 mg; n = 381), or placebo (saline; n = 395). The drug infusion started 30 minutes before and continued for 6 hours after endoscopy. Patients were evaluated clinically, and serum amylase levels were determined at 4, 24, and 48 hours after endoscopy.


RESULTS
No significant differences in incidences of pancreatitis, hyperamylasemia, or abdominal pain were observed among the placebo (4.8%, 32.6%, and 5.3%, respectively), somatostatin (6.3%, 26.8%, and 5.1%, respectively), and gabexate mesylate groups (5.8%, 31.5%, and 6.3%, respectively). Univariate analysis of patient characteristics and endoscopic maneuvers showed that a Freeman score >1 (P < 0.0001), >/=3 pancreatic injections (P < 0.00001), and precut sphincterotomy (P = 0.01) were significantly associated with post-ERCP pancreatitis. At multiple logistic regression analysis, >/=3 pancreatic injections (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.45-2.63) and a Freeman score >1 (OR, 1.47; 95% CI, 1.11-1.94) retained their predictive power.


CONCLUSIONS
Long-term (6.5-hr) administration of either somatostatin or gabexate mesylate is ineffective for the prevention of post-ERCP pancreatitis. Pancreatic injury seems to be related to difficulty in common bile duct access.
Division of Gatroenterology, Casa Sollievo della Sofferenza Hospital-Istituto Ricovero Cura Carattere Scientifico, San Giovanni Rotondo, Italy. a.andriulli@operapadrepio.it
Angelo
A
Andriulli
Luigi
L
Solmi
Silvano
S
Loperfido
Pietro
P
Leo
Virginia
V
Festa
Angelo
A
Belmonte
Fulvio
F
Spirito
Michele
M
Silla
Giovambattista
G
Forte
Vittorio
V
Terruzzi
Giorgio
G
Marenco
Enrico
E
Ciliberto
Antonio
A
Sabatino
Fabio
F
Monica
Maria Rita
MR
Magnolia
Francesco
F
Perri
D000368:Aged; D000369:Aged, 80 and over; D018890:Chemoprevention / Q000379:methods; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D016670:Gabexate / Q000627:therapeutic use*; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D013004:Somatostatin / Q000627:therapeutic use*; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D016670:Gabexate; D013004:Somatostatin