Department of Oncology, Fu Xing Hospital Affiliated to Capital Medical University, Beijing, China (mainland).
Department of Hepatobiliary Surgery, Chinese PLA Air Force Medical Center, Beijing, China (mainland).
Med Sci Monit. 2022 Sep 15;28:e936863. doi: 10.12659/MSM.936863.
BACKGROUND In patients with advanced malignant obstructive jaundice (MOJ), it remains an intractable problem to maintain biliary patency, because repeated stent occlusion and poor immune condition can lead to serious infection. The aim of this study was to investigate the effect of endobiliary ablation combined with immune nutrition (IN) on advanced MOJ. MATERIAL AND METHODS A prospective randomized pilot study of patients undergoing percutaneous transhepatic biliary drainage (PTBD) for advanced MOJ was conducted. From January 2018 to December 2020, patients fulfilling eligibility criteria were enrolled and randomized into 2 groups: patients who received only PTBD and standard early enteral nutrition were defined as the control group, and those who underwent additional endobiliary ablation and early IN on basis of the standard therapy were defined as the study group. Primary outcome was assessment of the quality of life based on time to resuming normal daily activities, duration of stent patency, and the overall survival (OS). Secondary outcomes included time before relief of jaundice, hospital stay, inflammation responses, and related complications. RESULTS We included 59 patients: 28 in the study group and 31 in the study group. Baseline characteristics were well balanced between the 2 groups. No statistically significant difference was found in time to resuming normal daily activities between the 2 groups. However, the study group presented statistically longer median duration of stent patency and survival time compared to the control group (stent patency 10.2 months vs 6.8 months, survival 9.6 months vs 7.1 months). The median time for relief of jaundice and the incidence of infection were similar between the 2 groups, but values of inflammatory response markers 3 days after the operation were significantly lower in the study group. No significant difference was found between the 2 groups in overall incidence of complications. CONCLUSIONS For patients at the advanced stage of MOJ, endobiliary ablation combined with postoperative IN therapy can significantly improve the quality of life.
在晚期恶性梗阻性黄疸(MOJ)患者中,保持胆道通畅仍然是一个棘手的问题,因为反复的支架阻塞和较差的免疫状况会导致严重的感染。本研究旨在探讨胆道内消融联合免疫营养(IN)对晚期 MOJ 的治疗效果。
本研究为前瞻性随机对照研究,纳入 2018 年 1 月至 2020 年 12 月期间接受经皮经肝胆道引流(PTBD)治疗的晚期 MOJ 患者。符合入选标准的患者被随机分为 2 组:仅接受 PTBD 和标准早期肠内营养的患者为对照组,在标准治疗基础上接受额外胆道内消融和早期 IN 的患者为研究组。主要结局是基于恢复正常日常活动的时间、支架通畅时间和总生存(OS)来评估生活质量。次要结局包括黄疸缓解时间、住院时间、炎症反应和相关并发症。
共纳入 59 例患者,其中研究组 28 例,对照组 31 例。两组患者的基线特征均衡。两组患者恢复正常日常活动的时间无统计学差异。然而,研究组的支架通畅时间和生存时间均明显长于对照组(支架通畅时间 10.2 个月 vs 6.8 个月,生存时间 9.6 个月 vs 7.1 个月)。两组患者黄疸缓解时间和感染发生率相似,但研究组术后 3 天炎症反应标志物水平明显较低。两组患者的总并发症发生率无统计学差异。
对于晚期 MOJ 患者,胆道内消融联合术后 IN 治疗可显著提高生活质量。