Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands.
Ann Surg. 2010 Nov;252(5):840-9. doi: 10.1097/SLA.0b013e3181fd36a2.
To evaluate the relation between delay in surgery because of preoperative biliary drainage (PBD) and survival in patients scheduled for surgery for pancreatic head cancer.
Patients with obstructive jaundice due to pancreatic head cancer can undergo PBD. The associated delay of surgery can lead to more advanced cancer stages at surgical exploration, affecting resection rate and survival.
We conducted a multicenter, randomized controlled clinical trial to compare PBD with early surgery (ES) for pancreatic head cancer for complications. We obtained Kaplan-Meier estimates of overall survival for patients with pathology-proven malignancy and compared survival functions of ES and PBD groups using log-rank test statistics. Multivariable Cox regression analyses were performed to evaluate the prognostic role of time to surgery for overall survival.
Mean times from randomization to surgery were 1.2 (0.9-1.5) and 5.1 (4.8-5.5) weeks in the ES and PBD groups, respectively (P < 0.001). In the ES group, 60 (67%) of 89 patients underwent resection, versus 53 (58%) of 91 patients in the PBD group (P = 0.20). Median survival after randomization was 12.2 (9.1-15.4) months in the ES group versus 12.7 (8.9-16.6) months in the PBD group (P = 0.91). A longer time to surgery was significantly associated with slightly lower mortality rate after surgery (hazard ratio = 0.90, 95% CI, 0.83-0.97), when taking into account resection, bilirubin, complications, pancreatic adenocarcinoma, tumor-positive lymph nodes, and microscopically residual disease.
In patients with pancreatic head cancer, the delay in surgery associated with PBD does not impair or benefit survival rate.
评估因术前胆道引流(PBD)而导致手术延迟与胰头癌患者生存之间的关系。
因胰头癌导致梗阻性黄疸的患者可接受 PBD。手术相关的延迟会导致手术探查时癌症分期更晚,从而影响切除率和生存率。
我们进行了一项多中心、随机对照临床试验,比较了胰头癌的 PBD 与早期手术(ES)治疗的并发症。我们获得了病理学证实恶性肿瘤患者的总生存 Kaplan-Meier 估计,并使用对数秩检验统计量比较了 ES 和 PBD 组的生存函数。进行多变量 Cox 回归分析以评估手术时间对总生存的预后作用。
ES 组和 PBD 组的随机分组至手术的平均时间分别为 1.2(0.9-1.5)和 5.1(4.8-5.5)周(P < 0.001)。ES 组 89 例患者中有 60 例(67%)接受了切除术,而 PBD 组 91 例中有 53 例(58%)(P = 0.20)。随机分组后的中位生存时间在 ES 组为 12.2(9.1-15.4)个月,在 PBD 组为 12.7(8.9-16.6)个月(P = 0.91)。考虑到切除、胆红素、并发症、胰腺腺癌、阳性淋巴结、显微镜下残留疾病等因素,手术时间的延长与手术后死亡率略降低显著相关(风险比=0.90,95%CI,0.83-0.97)。
在胰头癌患者中,与 PBD 相关的手术延迟不会损害或提高生存率。