Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial.
BACKGROUND
ERCP is frequently complicated by pancreatitis. The aims of this study were to assess the efficacy of somatostatin and gabexate for prevention of post-ERCP pancreatitis in high-risk patients and to determine predisposing factors for post-ERCP pancreatitis. A meta-analysis was conducted of all published studies on the use of somatostatin or gabexate for prevention of post-ERCP pancreatitis.


METHODS
A double blind, multicenter, placebo-controlled trial was conducted in patients at high risk for post-ERCP pancreatitis. Patients were randomized to receive an intravenous infusion of somatostatin (750 mg), gabexate (500 mg), or placebo that was started 30 minutes before endoscopy and continued for 2 hours afterward. Patients were evaluated clinically and serum amylase levels determined at 4 and 24 hours after endoscopy.


RESULTS
No significant difference in the occurrence of pancreatitis, hyperamylasemia, or abdominal pain was observed among placebo-, gabexate-, and somatostatin-treated patients. A sphincterotomy longer than 2 cm (p = 0.0001), more than 3 pancreatic injections (p = 0.0001), and unsuccessful cannulation (p = 0.008) were predictive of post-ERCP pancreatitis. Hyperamylasemia was predicted by more than 3 pancreatic injections (p = 0.0001) and sphincterotomy (p = 0.02). The meta-analysis of trials of short-term infusion of gabexate or somatostatin did not show efficacy for either drug.


CONCLUSIONS
Short-term administration of gabexate or somatostatin in patients at high risk for pancreatitis is ineffective for prevention of ERCP-induced pancreatitis. Pancreatic injury is related to maneuvers used to obtain biliary access rather than to any patient characteristic or endoscopist experience.
Andriulli
Angelo
A
Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.
Clemente
Rocco
R
Solmi
Luigi
L
Terruzzi
Vittorio
V
Suriani
Renzo
R
Sigillito
Angelo
A
Leandro
Gioacchino
G
Leo
Pietro
P
De Maio
Giovanni
G
Perri
Francesco
F
D000208:Acute Disease; D000328:Adult; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D002983:Clinical Competence; D004311:Double-Blind Method; D005260:Female; D016670:Gabexate / Q000627:therapeutic use*; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D034321:Hyperamylasemia / Q000097:blood; D008297:Male; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology* / Q000517:prevention & control*; D015990:Placebo Effect; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D012307:Risk Factors; D015842:Serine Proteinase Inhibitors / Q000627:therapeutic use*; D013004:Somatostatin / Q000627:therapeutic use*; D016717:Sphincterotomy, Endoscopic; D016896:Treatment Outcome
D006728:Hormones; D015842:Serine Proteinase Inhibitors; D016670:Gabexate; D013004:Somatostatin