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Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial.
Endoscopy. 2015 May; 47(5):415-20.E

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).

Authors+Show Affiliations

Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.Department of Gastroenterology, Heilongjiang Province Hospital, Harbin, China.Department of Gastroenterology, First People's Hospital of Hangzhou, Hangzhou, Zhejiang, China.Department of Gastroenterology, First Affiliated Hospital, Nan Chang University, Jiangxi, China.Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Department of Gastroenterology, First People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.Department of Gastroenterology, Urumchi General Hospital, Lanzhou Command, PLA, China.Gastrointestinal Endoscopy Center, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu, China.Department of Gastroenterology, Southwest Hospital, Third Military Medical University, Chongqing, China.Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25590178

Citation

Bai, Yu, et al. "Prophylactic Somatostatin Can Reduce Incidence of post-ERCP Pancreatitis: Multicenter Randomized Controlled Trial." Endoscopy, vol. 47, no. 5, 2015, pp. 415-20.
Bai Y, Ren X, Zhang XF, et al. Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial. Endoscopy. 2015;47(5):415-20.
Bai, Y., Ren, X., Zhang, X. F., Lv, N. H., Guo, X. G., Wan, X. J., Nie, Z. G., Han, S. T., Bie, P., Tian, D. A., Ji, M., & Li, Z. S. (2015). Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial. Endoscopy, 47(5), 415-20. https://doi.org/10.1055/s-0034-1391227
Bai Y, et al. Prophylactic Somatostatin Can Reduce Incidence of post-ERCP Pancreatitis: Multicenter Randomized Controlled Trial. Endoscopy. 2015;47(5):415-20. PubMed PMID: 25590178.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial. AU - Bai,Yu, AU - Ren,Xu, AU - Zhang,Xiao-Feng, AU - Lv,Nong-Hua, AU - Guo,Xue-Gang, AU - Wan,Xin-Jian, AU - Nie,Zhan-Guo, AU - Han,Shu-Tang, AU - Bie,Ping, AU - Tian,De-An, AU - Ji,Ming, AU - Li,Zhao-Shen, Y1 - 2015/01/15/ PY - 2015/1/16/entrez PY - 2015/1/16/pubmed PY - 2016/2/19/medline SP - 415 EP - 20 JF - Endoscopy JO - Endoscopy VL - 47 IS - 5 N2 - 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). SN - 1438-8812 UR - https://www.unboundmedicine.com/medline/citation/25590178/Prophylactic_somatostatin_can_reduce_incidence_of_post_ERCP_pancreatitis:_multicenter_randomized_controlled_trial_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0034-1391227 DB - PRIME DP - Unbound Medicine ER -