Efficacy of 2-Mercaptoethane Sulfonate Sodium (MESNA) in the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Randomized Open Label Trial
Amir Sadeghi, Hesamoddin Samar, Mohammad Abbasinazari, Parvaneh Mohammadi, Ali Abazarikia, Shadi Ziaie
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Abstract
Background and Aim
Oxidative stress has been considered a factor in the development of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). The present clinical trial evaluated whether adding intravenous mesna to rectal indomethacin could prevent or alleviate PEP.
Methods
An open-labeled clinical trial was done on 698 participants undergoing endoscopic retrograde cholangiopancreatography (ERCP). Eligible patients received 100 mg indomethacin suppository 30 min before undergoing ERCP. Randomly, the participants received 400 mg intravenous mesna or nothing 30 min before doing the procedure. The PEP incidence and degree were measured in the patients as the main outcome.
Results
The total rate of PEP was equal to 13.7%. No significant difference was seen in the rate and severity of PEP between the mesna plus indomethacin and indomethacin alone arms (14% vs. 13.4%, respectively, p = 0.671). In high-risk patients, PEP rate and severity were lower in the mesna plus indomethacin group compared with indomethacin alone group and the statistical analysis showed that the difference was significant (41.7% vs. 51.8%, respectively, p = 0.033).
Conclusion
In high-risk patients undergoing ERCP, a combination of intravenous mesna plus rectal indomethacin may decrease the PEP rate and severity.
背景和目的:氧化应激被认为是内镜后逆行胆管胰腺炎(PEP)发展的一个因素。本临床试验评价在直肠吲哚美辛基础上静脉加用肠系膜是否能预防或缓解PEP。方法:对698名接受内窥镜逆行胆管胰胆管造影(ERCP)的参与者进行开放标签临床试验。符合条件的患者在ERCP术前30分钟给予100mg吲哚美辛栓剂。随机地,参与者在手术前30分钟接受400毫克静脉注射或不注射。以患者PEP发生率及程度为主要观察指标。结果:PEP总有效率为13.7%。mesna联合吲哚美辛组与单独使用吲哚美辛组在PEP发生率和严重程度上无显著差异(分别为14%和13.4%,p = 0.671)。高危患者中,mesna联合吲哚美辛组PEP发生率和严重程度均低于单用吲哚美辛组,差异有统计学意义(41.7% vs 51.8%, p = 0.033)。结论:在高危ERCP患者中,静脉肠系膜联合直肠吲哚美辛可降低PEP发生率和严重程度。