| Background:ERCP has become one of the most important measures of diagnosis and treatment of pancreas and bile duct diseases, but as an invasive operation, associated complications were not rare. Studies showed BEND had the advantages of simple operation, convenient observation of draining night, prevention and treatment of complications with good effect, but due to small sample size, single center study, the conclusion was not consistent. So, the effectiveness of ENBD on the prevention and treatment of complications related to ERCP is still controversial, none of evidence-based science basis.Objective:To determine the effectiveness of ENBD on the prevention and treatment of complications related to ERCP, such as hyperamylasemia, PEP, SPEP, acute cholangitis, ACST, gastrointestinal bleeding, intestinal perforation and death.Methods:Electronic search was performed in Pub Med, Medline, Cochrane Library databases, Web of SCI, CNKI, Chinese Technological Journals Database, Wan Fang Digital Journal Full-text Database and CQVIP from databases establishment to March2015, language was limited to English or Chinese. And we hand-searched the date from the proceedings of correlated conferences. Besides, all references in included trials were searched, too. According to pre-established inclusion and exclusion criteria,literature identification, data extraction, and quality assessment were performed by two reviewers independently. Newcastle-Ottawa scale was applied for quality assessment. Statistical analysis was performed by Meta analysis using Review Manager 5.3 which offered by Cochrane.Results:A total of 18 trials involving 1952 in ENBD group patients and 1577 patients in no-ENBD group were included, the results of systematic review showed that: ⑴ The effectiveness of ENBD on the prevention of hyperamylasemia: P<0.00001, OR=0.50(95%CI=0.37~0.67), NNT=26. Sensitivity analysis result and the original Meta analysis had the same conclusions, P<0.00001, OR=0.55(95%CI=0.39~0.76).Publication bias test showed that the funnel plot was roughly symmetrical, Begg’s test Z=1.07, P=0.283. ⑵ The effectiveness of ENBD on the prevention of PEP:P<0.00001, OR=0.27(95%CI=0.19~0.38), NNT=11. Sensitivity analysis result and the original Meta analysis had the same conclusions, P<0.00001, OR=0.28(95%CI=0.19~0.39). Publication bias test showed that the funnel plot lacked the lower right corner, but all the trials were located within the 95%CI, and Begg’s test Z=1.71, P=0.086. ⑶ The effectiveness of ENBD on the prevention of SPEP: P=0.03,OR=0.19(95%CI=0.04~0.88). Sensitivity analysis result lost statistically significant differences, P=0.09, OR=0.22(95%CI=0.04~1.30). But in ENBD group the incidence of SPEP was 0.3%, significantly lower than that in no-ENBD group, which was 3.4%.⑷ The effectiveness of ENBD on the prevention of acute cholangitis: P<0.00001,OR=0.25(95%CI=0.14~0.45), NNT=20. Sensitivity analysis result and the original Meta analysis had the same conclusions, P<0.00001, OR=0.25(95%CI=0.14~0.45).Publication bias test showed that the funnel plot was roughly symmetrical, Begg’s test P=1.000. ⑸ The effectiveness of ENBD on the prevention of ACST: P=0.009,OR=0.10(95%CI=0.02~0.57), NNT=33. ⑹ The effectiveness of ENBD on the prevention of gastrointestinal bleeding: P=0.89, OR=0.92(95%CI=0.32~2.68).Sensitivity analysis result and the original Meta analysis had the same conclusions,P=0.89, OR=1.09(95%CI=0.33~3.64). ⑺ Effect of ENBD on mortality: P=0.08,OR=0.20(95%CI=0.03~1.20). The difference was not statistically significant, but the mortality was 0.1% in ENBD group, significantly lower than that in no-ENBD group,which was 1.1%. ⑻ The effect of ENBD on surgery rate related to post-ERCP complications: P=0.001, OR=0.09(95%CI=0.02~0.40). Sensitivity analysis result lost statistically significant differences, P=0.08, OR=0.15(95%CI=0.02~1.24). But in ENBD group the surgery rate was 0.1%, significantly lower than that in no-ENBD group, which was 2.6%. ⑼ The effect of ENBD on post-ERCP hospital stays: P=0.21,WMD=-0.81d(95%CI=-2.09d~0.46d). ⑽ The effect of ENBD on the efficacy of ERCP: Part of the included studies reported ENBD could not effectively shorten the recovery time of serumal c-reactive protein, Alanine transaminase, bilirubin, or otherlaboratory parameters, but it could effectively shorten the recovery time of PEP patients. ⑾ The safety of ENBD: Part of the included studies reported the safety of ENBD, Neither ENBD lead to serious consequences.Conclusions:ENBD after ERCP could effectively reduce the incidence of hyperamylasemia,PEP and acute cholangitis. Especially ENBD could reduce the severe tendency of PEP and acute cholangitis, so the mortality of complications related to post-ERCP was more lower in ENBD group. In addition, ENBD could shorten the recovery time of PEP patients, especially could improve the medical cure rate for SPEP or ASCT patients. Besides, ENBD itself did not lead to adverse consequences. In summary,ENBD is a safe and and effective measure to prevent or treat complications related to post-ERCP, worthy of clinical application and popularization. |
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