Effect of octreotide administration in the prophylaxis of post-ERCP pancreatitis and hyperamylasemia: A multicenter, placebo-controlled, randomized clinical trial.
OBJECTIVE
Since the introduction of endoscopic retrograde cholangiopancreatology (ERCP) in clinical use, pancreatitis has become a common complication of ERCP. Octreotide is an inhibitor of pancreatic enzyme secretions. Several studies have evaluated the effect of octreotide on the incidence of clinical pancreatitis after ERCP, but with different results. The aim was to determine the efficacy of prophylactic administration of octreotide for the prevention of post-ERCP pancreatitis (PEP) and hyperamylasemia.


METHODS
In this study, patients with scheduled ERCP were randomized to receive either octreotide (0.3 mg) via intramuscular injection or a placebo. The study was conducted in 12 digestive endoscopic units in China. Patients were randomized into two groups: an octreotide group (N = 414) and a control group (N = 418). In the octreotide group, octreotide (0.3 mg) was dissolved in 500 mL of 0.9% saline solution and administered by continuous intravenous infusion, beginning 1 h before endoscopic examination and continued for 6 h thereafter; 0.1 mg of octreotide was injected subcutaneously at 6 and 12 h after the intravenous injection was stopped. The control group was given a placebo intravenously. The end point was the development of acute pancreatitis.


RESULTS
The overall incidence of acute pancreatitis was 3.85%; this included 2.42% (10/414) in the octreotide group and 5.26% (22/418) in the control group (P = 0.046). The overall incidence of hyperamylasemia was 14.9%; 12.32% (51/414) in the octreotide group and 17.46% (73/418) in the control group (P = 0.041). No side effects were found.


CONCLUSIONS
The results indicate that octreotide can prevent PEP and hyperamylasemia.
Li
Zhao-Shen
ZS
Department of Gastroenterology, Changhai Hospital, SMMU, Shanghai, China.
Pan
Xue
X
Zhang
Wen-Jun
WJ
Gong
Biao
B
Zhi
Fa-Chao
FC
Guo
Xue-Gang
XG
Li
Pei-Ming
PM
Fan
Zhi-Ning
ZN
Sun
Wen-Sheng
WS
Shen
Yun-Zhi
YZ
Ma
Shu-Ren
SR
Xie
Wei-Fen
WF
Chen
Min-Hu
MH
Li
Yan-Qing
YQ
D002681:China / Q000453:epidemiology; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D034321:Hyperamylasemia / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D010919:Placebos; D012307:Risk Factors; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D010919:Placebos; D015282:Octreotide