Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial

Yu Bai; Xu Ren; Xiao-Feng Zhang; Nong-Hua Lv; Xue-Gang Guo; Xin-Jian Wan; Zhan-Guo Nie; Shu-Tang Han; Ping Bie; De-An Tian; Ming Ji; Zhao-Shen Li

doi:10.1055/s-0034-1391227

Endoscopy, Table of Contents

Endoscopy 2015; 47(05): 415-420
DOI: 10.1055/s-0034-1391227

Original article

Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial

Yu Bai^*

¹Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China

,

Xu Ren^**

²Department of Gastroenterology, Heilongjiang Province Hospital, Harbin, China

,

Xiao-Feng Zhang^*

³Department of Gastroenterology, First People’s Hospital of Hangzhou, Hangzhou, Zhejiang, China

,

Nong-Hua Lv^**

⁴Department of Gastroenterology, First Affiliated Hospital, Nan Chang University, Jiangxi, China

,

Xue-Gang Guo^*

⁵Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China

,

Xin-Jian Wan

⁶Department of Gastroenterology, First People’s Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

,

Zhan-Guo Nie

⁷Department of Gastroenterology, Urumchi General Hospital, Lanzhou Command, PLA, China

,

Shu-Tang Han

⁸Gastrointestinal Endoscopy Center, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu, China

,

Ping Bie

⁹Department of Gastroenterology, Southwest Hospital, Third Military Medical University, Chongqing, China

,

De-An Tian

¹⁰Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

,

Ming Ji

¹¹Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China

,

Zhao-Shen Li^**

¹Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China

› Author Affiliations

Abstract

Background and study aim: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) remains the most common complication of ERCP. Somatostatin may inhibit pancreatic secretion and has been tested for PEP prophylaxis. However, the results of previous studies are inconsistent. The aim of the current study was to investigate whether somatostatin can reduce the incidence of PEP.

Patients and methods: The study was a multicenter, open-label, randomized controlled trial. A total of 908 patients with normal amylase levels who were undergoing ERCP were randomized to receive somatostatin 250 μg bolus injection before ERCP and 250 μg/hour intravenous infusion for 11 hours after ERCP (somatostatin group) or no somatostatin treatments (control group). The incidences of PEP and hyperamylasemia were compared in the two groups.

Results: The full analysis set included 900 patients (445 in the somatostatin group, 455 in the control group). PEP developed in 34 patients (7.5 %) in the control group (95 % confidence interval [CI] 5.4 % – 10.3 %) and in 18 patients (4.0 %) in the somatostatin group (95 %CI 2.6 % – 6.3 %; P = 0.03). Hyperamylasemia occurred in 46 patients (10.1 %) in the control group (95 %CI 7.7 % – 13.2 %) and in 27 patients (6.1 %) in the somatostatin group (95 %CI 4.2 % – 8.7 %; P = 0.03). No perforation or death occurred during the study.

Conclusions: This study showed that somatostatin was effective and safe for the prevention of PEP and hyperamylasemia in ERCP patients.

(ClinicalTrials.gov number, NCT01431781).

Full Text

References

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