Savader S J, Cameron J L, Lillemoe K D, Lund G B, Mitchell S E, Venbrux A C
Russell H. Morgan Department of Radiology, Johns Hopkins Hospital, Baltimore, MD 21287, USA.
J Vasc Interv Radiol. 1998 Nov-Dec;9(6):976-85. doi: 10.1016/s1051-0443(98)70436-1.
To evaluate the long-term predictive value of the biliary manometric perfusion test and clinical trial for determining patency after treatment of bile duct strictures.
One hundred four patients with benign biliary disease were treated with surgical (n = 59) or percutaneous (n = 45) techniques followed by intubation with large-caliber silicone stents. Prior to removal of the biliary stents, patients underwent a biliary manometric perfusion test (n = 168) and/or a clinical trial (n = 105) to objectively and subjectively evaluate the treated site for potential long-term patency. The patients were followed up for 1-87 months, and clinical outcomes were determined. Kaplan-Meier survival curves were generated for three patient groups, including those who (i) passed either test, (ii) failed either test, and (iii) failed either test, were re-treated, and passed either test.
Final successful treatment outcomes were documented in 47 (92%) surgically and 31 (86%) percutaneously treated patients, respectively (P = .001). The Kaplan-Meier survival curves determined the probability of patency at 0, 2, 4, and 6 years after treatment to be 1.0, .96, .78, and .59, respectively, after passing a biliary manometric perfusion test; and 1.0, .91, .78, and .78, respectively, after passing a clinical trial (P > .10). The probability of patency at 4 years after treatment was .45 after failing a biliary manometric perfusion test, and at 6 months was zero after failing a clinical trial (P = .001 and .001, respectively, vs the same test in the passing group). Seventy-nine percent of patients who failed either test required an additional period of repeated stent placement or reoperation. After repeated treatment, the probability of patency at 0-4 years was .80 and .88, respectively, for the biliary manometric perfusion test and clinical trial (P > .05 and P > .10, respectively, vs same test in the group that passed).
Patients who initially pass either the biliary manometric perfusion test or clinical trial have a significantly increased probability of patency versus those who fail; however, patients who fail either test and who then receive definitive additional treatment have a similar probability of patency as those who initially pass. Although the log rank test demonstrated the Kaplan-Meier survival curves from the biliary manometric perfusion test and clinical trial not to be significantly different in any of the three groups (ie, passing, failing, re-treated), the biliary manometric perfusion test is recommended over the clinical trial because of its simplicity, immediate results, and predicted cost savings.
评估胆管测压灌注试验和临床试验对胆管狭窄治疗后通畅性判定的长期预测价值。
104例良性胆道疾病患者接受了手术治疗（n = 59）或经皮治疗（n = 45），随后置入大口径硅胶支架。在拔除胆管支架前，患者接受了胆管测压灌注试验（n = 168）和/或临床试验（n = 105），以客观和主观地评估治疗部位的潜在长期通畅性。对患者进行了1至87个月的随访，并确定了临床结果。为三组患者绘制了Kaplan-Meier生存曲线，包括（i）通过任一试验的患者、（ii）任一试验失败的患者以及（iii）任一试验失败、接受再次治疗并通过任一试验的患者。
最终成功的治疗结果分别记录在47例（92%）接受手术治疗和31例（86%）接受经皮治疗的患者中（P = 0.001）。Kaplan-Meier生存曲线显示，通过胆管测压灌注试验后，治疗后0、2、4和6年通畅的概率分别为1.0、0.96、0.78和0.59；通过临床试验后，相应概率分别为1.0、0.91、0.78和0.78（P > 0.10）。胆管测压灌注试验失败后，治疗后4年通畅的概率为0.45；临床试验失败后，6个月时通畅概率为零（与通过组的相同试验相比，P分别为0.001和0.001）。任一试验失败的患者中有79%需要额外一段时间的重复支架置入或再次手术。再次治疗后，胆管测压灌注试验和临床试验在0至4年通畅的概率分别为0.80和0.88（与通过组的相同试验相比，P分别> 0.05和P > 0.10）。
最初通过胆管测压灌注试验或临床试验的患者与试验失败的患者相比，通畅的概率显著增加；然而，任一试验失败后接受确定性额外治疗的患者与最初通过试验的患者具有相似的通畅概率。尽管对数秩检验表明胆管测压灌注试验和临床试验的Kaplan-Meier生存曲线在三组（即通过、失败、再次治疗）中的任何一组中均无显著差异，但由于胆管测压灌注试验操作简单、结果即时且预计可节省成本，因此推荐采用该试验而非临床试验。
