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Gabexate in the prophylaxis of post-ERCP pancreatitis: a meta-analysis of randomized controlled trials.

Zheng M, Chen Y, Yang X, Li J, Zhang Y, Zeng Q - BMC Gastroenterol (2007)

Bottom Line: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography and the benefit of its pharmacological treatment is unclear.When the RCTs were analyzed, odds ratios (OR) for gabexate mesilate were 0.67 [95% CI (0.31 to approximately 1.47), p = 0.32] for PEP, 3.78 [95% CI (0.62 to approximately 22.98), p = 0.15] for severe PEP, 0.68 [95% CI (0.19 to approximately 2.43), p = 0.56] for the case-fatality of PEP, 0.88 [95% CI (0.72 to approximately 1.07), p = 0.20] for post-ERCP hyperamylasemia, 0.69 [95% CI (0.39 to approximately 1.21), p = 0.19] for post-ERCP abdominal pain, thus indicating no beneficial effects of gabexate on acute pancreatitis, the death rate of PEP, hyperamylasemia and abdominal pain.No evidence of publication bias was found.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Infection and Liver Disease, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China. blueman1320@163.com <blueman1320@163.com>

ABSTRACT

Background: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography and the benefit of its pharmacological treatment is unclear. Although prophylactic use of gabexate for the reduction of pancreatic injury after ERCP has been evaluated, the discrepancy about gabexate's beneficial effect on pancreatic injury still exists. This study aimed to evaluate the effectiveness and safety of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP).

Methods: We employed the method recommended by the Cochrane Collaboration to perform a meta-analysis of randomized controlled trials (RCTs) of gabexate in the prevention of post-ERCP pancreatitis (PEP) including three RCTs conducted in Italy and one in China.

Results: All of the four RCTs were of high quality. When the RCTs were analyzed, odds ratios (OR) for gabexate mesilate were 0.67 [95% CI (0.31 to approximately 1.47), p = 0.32] for PEP, 3.78 [95% CI (0.62 to approximately 22.98), p = 0.15] for severe PEP, 0.68 [95% CI (0.19 to approximately 2.43), p = 0.56] for the case-fatality of PEP, 0.88 [95% CI (0.72 to approximately 1.07), p = 0.20] for post-ERCP hyperamylasemia, 0.69 [95% CI (0.39 to approximately 1.21), p = 0.19] for post-ERCP abdominal pain, thus indicating no beneficial effects of gabexate on acute pancreatitis, the death rate of PEP, hyperamylasemia and abdominal pain. No evidence of publication bias was found.

Conclusion: Gabexate mesilate can not prevent the pancreatic injury after ERCP. It is not recommended for the use of gabexate mesilate in the prophylaxis of PEP.

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Effect of gabexate on the frequency of ERCP-related acute pancreatitis, severe pancreatitis, case-fatality ratio, post-ERCP hyperamylasemia and post-ERCP abdominal pain.
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Figure 2: Effect of gabexate on the frequency of ERCP-related acute pancreatitis, severe pancreatitis, case-fatality ratio, post-ERCP hyperamylasemia and post-ERCP abdominal pain.

Mentions: In this report, we considered PEP as the primary outcome which was divided into general PEP and severe PEP. The report of general PEP was noticed in all four RCTs [4,7-9]. These trials included 1783 patients with 104 patients suffering from PEP. Among PEP-suffering patients, 46 patients were treated with gabexate whereas 58 patients were treated with placebo. There was a significant heterogeneity among these studies (Q = 9.26, 3 degrees of freedom, p = 0.03). However, analysis by random-effects model indicated a DL random-effect pooled OR = 0.67 [(95 percent CI 0.31 to 1.47); p = 0.32] with no significant association between the use of gabexate and the reduction of PEP (Figure 2).


Gabexate in the prophylaxis of post-ERCP pancreatitis: a meta-analysis of randomized controlled trials.

Zheng M, Chen Y, Yang X, Li J, Zhang Y, Zeng Q - BMC Gastroenterol (2007)

Effect of gabexate on the frequency of ERCP-related acute pancreatitis, severe pancreatitis, case-fatality ratio, post-ERCP hyperamylasemia and post-ERCP abdominal pain.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC1803791&req=5

Figure 2: Effect of gabexate on the frequency of ERCP-related acute pancreatitis, severe pancreatitis, case-fatality ratio, post-ERCP hyperamylasemia and post-ERCP abdominal pain.
Mentions: In this report, we considered PEP as the primary outcome which was divided into general PEP and severe PEP. The report of general PEP was noticed in all four RCTs [4,7-9]. These trials included 1783 patients with 104 patients suffering from PEP. Among PEP-suffering patients, 46 patients were treated with gabexate whereas 58 patients were treated with placebo. There was a significant heterogeneity among these studies (Q = 9.26, 3 degrees of freedom, p = 0.03). However, analysis by random-effects model indicated a DL random-effect pooled OR = 0.67 [(95 percent CI 0.31 to 1.47); p = 0.32] with no significant association between the use of gabexate and the reduction of PEP (Figure 2).

Bottom Line: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography and the benefit of its pharmacological treatment is unclear.When the RCTs were analyzed, odds ratios (OR) for gabexate mesilate were 0.67 [95% CI (0.31 to approximately 1.47), p = 0.32] for PEP, 3.78 [95% CI (0.62 to approximately 22.98), p = 0.15] for severe PEP, 0.68 [95% CI (0.19 to approximately 2.43), p = 0.56] for the case-fatality of PEP, 0.88 [95% CI (0.72 to approximately 1.07), p = 0.20] for post-ERCP hyperamylasemia, 0.69 [95% CI (0.39 to approximately 1.21), p = 0.19] for post-ERCP abdominal pain, thus indicating no beneficial effects of gabexate on acute pancreatitis, the death rate of PEP, hyperamylasemia and abdominal pain.No evidence of publication bias was found.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Infection and Liver Disease, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China. blueman1320@163.com <blueman1320@163.com>

ABSTRACT

Background: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography and the benefit of its pharmacological treatment is unclear. Although prophylactic use of gabexate for the reduction of pancreatic injury after ERCP has been evaluated, the discrepancy about gabexate's beneficial effect on pancreatic injury still exists. This study aimed to evaluate the effectiveness and safety of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP).

Methods: We employed the method recommended by the Cochrane Collaboration to perform a meta-analysis of randomized controlled trials (RCTs) of gabexate in the prevention of post-ERCP pancreatitis (PEP) including three RCTs conducted in Italy and one in China.

Results: All of the four RCTs were of high quality. When the RCTs were analyzed, odds ratios (OR) for gabexate mesilate were 0.67 [95% CI (0.31 to approximately 1.47), p = 0.32] for PEP, 3.78 [95% CI (0.62 to approximately 22.98), p = 0.15] for severe PEP, 0.68 [95% CI (0.19 to approximately 2.43), p = 0.56] for the case-fatality of PEP, 0.88 [95% CI (0.72 to approximately 1.07), p = 0.20] for post-ERCP hyperamylasemia, 0.69 [95% CI (0.39 to approximately 1.21), p = 0.19] for post-ERCP abdominal pain, thus indicating no beneficial effects of gabexate on acute pancreatitis, the death rate of PEP, hyperamylasemia and abdominal pain. No evidence of publication bias was found.

Conclusion: Gabexate mesilate can not prevent the pancreatic injury after ERCP. It is not recommended for the use of gabexate mesilate in the prophylaxis of PEP.

Show MeSH
Related in: MedlinePlus