University of Michigan Medical Center, Ann Arbor, Michigan, USA.
Endoscopy. 2011 Apr;43(4):325-30. doi: 10.1055/s-0030-1256305. Epub 2011 Mar 31.
Temporary prophylactic pancreatic duct stenting effectively reduces post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk patients, but the optimal stent remains unclear. We compared rate of spontaneous passage, and technical difficulty of placement for 3-Fr and 5-Fr stents.
A randomized controlled trial at a single academic medical center. Patients deemed high risk for PEP randomly received 5-Fr or 3-Fr pancreatic duct stents. Primary outcome was spontaneous stent passage by 2 weeks. Secondary outcomes were ease and time for stent placement, and number of guide wires required for the entire procedure.
Patients (69 female [89 %]; mean age 44.9 years, standard deviation [SD] 16.8) were randomly assigned to receive 5-Fr (n = 38) and 3-Fr (n = 40) stents. Indications for stenting were similar. Seven patients in the 3-Fr group actually received a 5-Fr stent, and two in the 5-Fr group had a 3-Fr stent. Spontaneous passage or non-passage was confirmed in 64 (83 %). No statistically significant difference in spontaneous passage rates was seen (5-Fr group, 68.4 %; 3-Fr group 75.0 %; P = 0.617). Non-passage rates were 10.5 % (5-Fr group) and 10.0 % (3-Fr group) ( P = 1.00). The study was stopped after a futility analysis for the primary end point. Placement of 5-Fr stents was rated easier, at a mean score of 1.8 (5-Fr) vs. 3.4 (3-Fr), P < 0.001, with a trend towards being faster, 9.2 vs. 11.1 minutes ( P = 0.355). Fewer guide wires were required for 5-Fr stent placement, 1.5 vs. 1.9 ( P = 0.002). PEP rates did not differ ( P = 0.519).
Placement of 5-Fr compared to 3-Fr pancreatic duct stents for PEP prophylaxis is easier, faster, and requires fewer wires. No statistically significant difference in spontaneous passage was found between the two sizes.
临时预防性胰管支架置入术可有效降低内镜逆行胰胆管造影术（ERCP）后胰腺炎（PEP）的发生风险，尤其是在高危患者中。但目前尚不清楚哪种支架的效果最佳。本研究旨在对比 3Fr 和 5Fr 支架的自发排出率和置入技术难度。
本研究为单中心、随机对照试验。将被认为有发生 PEP 高危风险的患者随机分为 5Fr 组或 3Fr 组，分别接受胰管内 5Fr 或 3Fr 支架置入。主要结局为 2 周内支架的自发排出。次要结局包括支架置入的难易程度、所需时间以及整个操作过程中所需导丝的数量。
共纳入 69 例女性（89%）患者，平均年龄为 44.9 岁（标准差 16.8 岁），随机分配至 5Fr 组（n=38）或 3Fr 组（n=40）。两组患者的支架置入指征相似。3Fr 组中有 7 例患者实际置入了 5Fr 支架，5Fr 组中有 2 例患者置入了 3Fr 支架。64 例（83%）患者确认支架发生了自发排出或未排出。两组患者的自发排出率无统计学差异（5Fr 组为 68.4%，3Fr 组为 75.0%，P=0.617）。未排出的患者中，5Fr 组有 10.5%，3Fr 组有 10.0%（P=1.00）。由于主要结局的无效性分析，该研究提前终止。5Fr 支架的置入被认为更容易，平均评分为 1.8（5Fr 组）vs. 3.4（3Fr 组），P<0.001，且速度更快，5Fr 组为 9.2 分钟，3Fr 组为 11.1 分钟（P=0.355）。5Fr 支架置入所需的导丝更少，为 1.5 根 vs. 1.9 根（P=0.002）。两组患者的 PEP 发生率无差异（P=0.519）。
与 3Fr 支架相比，5Fr 支架用于 PEP 预防时更容易置入、速度更快、所需导丝更少。两种支架尺寸之间的自发排出率无统计学差异。
