Katsinelos Panagiotis, Lazaraki Georgia, Chatzimavroudis Grigoris, Katsinelos Taxiarchis, Georgakis Nikos, Anastasiadou Kyriaki, Gatopoulou Anthi, Zeglinas Christos, Psarras Kyriakos, Kountouras Jannis
a Division of Gastroenterology, Second Department of Internal Medicine , Ippokration Hospital, Medical School of Aristotle University , Thessaloniki , Greece.
b Second Department of Internal Medicine , Ippokration Hospital, Medical School of Aristotle University , Thessaloniki , Greece.
Scand J Gastroenterol. 2017 Jan;52(1):50-55. doi: 10.1080/00365521.2016.1228117. Epub 2016 Oct 3.
Easy common bile duct (CBD) cannulation is associated with low complication rate. This study aimed to investigate the potential impact of nitroglycerin and glucagon administration on selective CBD cannulation and prevention of post-ERCP pancreatitis.
A prospective single center, double-blind randomized study in which a total of 455 patients were randomly assigned to CBD cannulation by receiving 6 puffs (2.4 mg) sublingual nitroglycerin and glucagon 1 mg intravenously (n = 227, group A) or 6 puffs sterile water and 20 mg hyoscine-n-butyl bromide intravenously (n = 228, group B). After ERCP, patients were followed for the development of drugs' side-effects and post-ERCP complications.
There were no statistically significant differences between the two groups regarding demographic data and ERCP findings. Success rate of selective CΒD cannulation was 95.15% in group A versus 82.29% in group B (p < .001). Time required for CBD cannulation was 2.82 ± 2.31 min in group A versus 4.27 ± 3.84 min in group B (p = .021). Needle-knife papillotomy was used in 11 (4.85%) patients of group A and 39 (17.11%) patients of group B (p = .001). The frequency of post-ERCP pancreatitis was significantly lower in group A than in group B (3.08% versus 7.46%, p = .037). No difference was observed between the two groups with regard to the occurrence of post-procedure hemorrhage. There was no procedure-related mortality; no adverse event related to the combination regimen was observed.
Combined nitroglycerin and glucagon administration achieves a high selective CBC cannulation rates with concomitant reduction of post-ERCP pancreatitis incidence. However, further relative large-scale studies are needed to confirm our findings before definite conclusions can be drawn (Clinical trial registration number: NT: 4321).
容易进行胆总管（CBD）插管与低并发症发生率相关。本研究旨在探讨舌下含服硝酸甘油和静脉注射胰高血糖素对选择性CBD插管及预防内镜逆行胰胆管造影（ERCP）术后胰腺炎的潜在影响。
一项前瞻性单中心双盲随机研究，共455例患者被随机分配接受6喷（2.4毫克）舌下硝酸甘油和1毫克静脉注射胰高血糖素进行CBD插管（n = 227，A组），或6喷无菌水和20毫克静脉注射丁溴东莨菪碱（n = 228，B组）。ERCP术后，对患者进行随访，观察药物副作用及ERCP术后并发症的发生情况。
两组在人口统计学数据和ERCP检查结果方面无统计学显著差异。A组选择性CBD插管成功率为95.15%，B组为82.29%（p <.001）。A组CBD插管所需时间为2.82±2.31分钟，B组为4.27±3.84分钟（p =.021）。A组11例（4.85%）患者和B组39例（17.11%）患者使用了针刀乳头切开术（p =.001）。A组ERCP术后胰腺炎的发生率显著低于B组（3.08%对7.46%，p =.037）。两组术后出血的发生率无差异。无手术相关死亡；未观察到与联合用药方案相关的不良事件。
联合使用硝酸甘油和胰高血糖素可实现较高的选择性CBD插管率，同时降低ERCP术后胰腺炎的发生率。然而，在得出明确结论之前，需要进一步的相对大规模研究来证实我们的发现（临床试验注册号：NT：4321）。
