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放射性支架置入术治疗无法手术切除的肝门部胆管癌:一项前瞻性随机对照试验。

Radioactive stent insertion for inoperable hilar cholangiocarcinoma: a prospective randomized controlled trial.

作者信息

Song Tao, Feng An-Qiang, Fu Yu-Fei, Cao Chi, Wang You-Bin, Feng Jin-Ling

机构信息

Department of Gastrointestinal Surgery, Xuzhou Central Hospital, Xuzhou, China.

Department of Digestive Disease, Xuzhou Central Hospital, Xuzhou, China.

出版信息

Wideochir Inne Tech Maloinwazyjne. 2023 Jun;18(2):254-263. doi: 10.5114/wiitm.2022.123312. Epub 2022 Dec 22.

DOI:10.5114/wiitm.2022.123312
PMID:37680729
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10481449/
Abstract

INTRODUCTION

Hilar cholangiocarcinoma (HC) is the leading cause of hilar biliary obstruction. Radioactive stent insertion has been utilized extensively for inoperable HC patients.

AIM

To assess the relative clinical outcomes of inoperable HC patients who underwent either normal or radioactive stent insertion.

MATERIAL AND METHODS

This single-center, prospective, randomized, open-label study enrolled 90 inoperable HC patients from April 2021 to March 2022 and randomly assigned them to normal or radioactive stent groups (n = 45/group), with clinical data then being compared between these groups.

RESULTS

Technical success rates in the normal and radioactive stent insertion groups were 93.3% and 97.9%, respectively (p = 1.000), and clinical success rates were similarly consistent in both groups (95.3% vs. 97.7%, p = 0.983). Individuals in the radioactive stent group exhibited significantly longer median stent patency as compared to the normal stent group (195 days vs. 115 days, p < 0.001), and median overall survival (OS) was also significantly increased in the normal stent group (242 days vs. 125 days, p = 0.002). In the normal stent insertion group, 6 (14.3%) and 5 (11.9%) patients experienced early and late postoperative complications, respectively. Additionally, early and late postoperative complications impacted 7 (16.3%) and 8 (18.6%) patients in the radioactive stent insertion group, respectively. Complication rates were comparable in these 2 patient groups.

CONCLUSIONS

Radioactive stent insertion represents a safe and effective strategy for patients with inoperable HC, potentially contributing to prolonged stent patency and OS relative to normal stent insertion.

摘要

引言

肝门部胆管癌(HC)是肝门部胆管梗阻的主要原因。放射性支架置入已广泛应用于无法手术的HC患者。

目的

评估接受普通或放射性支架置入的无法手术的HC患者的相对临床结局。

材料与方法

本单中心、前瞻性、随机、开放标签研究纳入了2021年4月至2022年3月的90例无法手术的HC患者,并将他们随机分为普通支架组或放射性支架组(每组n = 45),然后比较两组的临床数据。

结果

普通支架置入组和放射性支架置入组的技术成功率分别为93.3%和97.9%(p = 1.000),两组的临床成功率同样一致(95.3%对97.7%,p = 0.983)。与普通支架组相比,放射性支架组患者的支架中位通畅时间显著更长(195天对115天,p < 0.001),普通支架组的中位总生存期(OS)也显著延长(242天对125天,p = 0.002)。在普通支架置入组中,分别有6例(14.3%)和5例(11.9%)患者发生早期和晚期术后并发症。此外,放射性支架置入组分别有7例(16.3%)和8例(18.6%)患者发生早期和晚期术后并发症。这两组患者的并发症发生率相当。

结论

对于无法手术的HC患者,放射性支架置入是一种安全有效的策略,相对于普通支架置入,可能有助于延长支架通畅时间和总生存期。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09d8/10481449/f8589b47e417/WIITM-18-49394-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09d8/10481449/b4cda7464842/WIITM-18-49394-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09d8/10481449/f8589b47e417/WIITM-18-49394-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09d8/10481449/b4cda7464842/WIITM-18-49394-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09d8/10481449/f8589b47e417/WIITM-18-49394-g002.jpg

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本文引用的文献

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Side-by-side versus stent-in-stent bilateral stenting for malignant hilar biliary obstruction: a meta-analysis.恶性肝门部胆管梗阻的并排支架置入术与支架内支架双侧支架置入术:一项荟萃分析
Wideochir Inne Tech Maloinwazyjne. 2022 Jun;17(2):279-288. doi: 10.5114/wiitm.2021.112477. Epub 2022 Jan 9.
2
Insertion of I-125 seed-loaded stent for inoperable hilar cholangiocarcinoma.I-125 粒子植入支架治疗不可切除肝门部胆管癌
Wideochir Inne Tech Maloinwazyjne. 2021 Dec;16(4):678-685. doi: 10.5114/wiitm.2021.105530. Epub 2021 Apr 20.
3
Endoscopic metal stenting for malignant hilar biliary obstruction: an update meta-analysis of unilateral versus bilateral stenting.
内镜金属支架置入术治疗恶性肝门部胆管梗阻:单侧与双侧支架置入术的最新荟萃分析
Wideochir Inne Tech Maloinwazyjne. 2021 Sep;16(3):472-481. doi: 10.5114/wiitm.2021.104196. Epub 2021 Mar 8.
4
Stent with radioactive strand insertion for inoperable hilar cholangiocarcinoma: comparison of unilateral and bilateral insertion.放射性strand 插入支架治疗不可切除肝门部胆管癌:单侧和双侧插入的比较。
Scand J Gastroenterol. 2021 Dec;56(12):1473-1479. doi: 10.1080/00365521.2021.1968945. Epub 2021 Aug 24.
5
Stent insertion for inoperable hilar cholangiocarcinoma: Comparison of radioactive and normal stenting.不可切除肝门部胆管癌支架置入术:放射性支架与普通支架比较。
Medicine (Baltimore). 2021 May 28;100(21):e26192. doi: 10.1097/MD.0000000000026192.
6
Covered metallic stent placement for biliary drainage could be promising in the coming era of neoadjuvant chemo-radiation therapy for all pancreatic cancer.对于接受新辅助放化疗的所有胰腺癌患者而言,胆道引流用覆膜金属支架置入术在未来可能具有广阔的应用前景。
J Hepatobiliary Pancreat Sci. 2021 Jul;28(7):617-624. doi: 10.1002/jhbp.958. Epub 2021 Apr 19.
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Irradiation stent insertion for inoperable malignant biliary obstruction: a meta-analysis of randomized controlled trials.不可手术恶性胆道梗阻患者内照射支架置入术的疗效:一项随机对照试验的荟萃分析。
Abdom Radiol (NY). 2021 May;46(5):2173-2181. doi: 10.1007/s00261-020-02851-6. Epub 2020 Nov 6.
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J Laparoendosc Adv Surg Tech A. 2021 Feb;31(2):203-209. doi: 10.1089/lap.2020.0400. Epub 2020 Jul 9.
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Stent with radioactive seeds strand insertion for malignant hilar biliary obstruction.带放射性种子的支架植入治疗恶性肝门胆管梗阻。
Minim Invasive Ther Allied Technol. 2021 Dec;30(6):356-362. doi: 10.1080/13645706.2020.1735446. Epub 2020 Mar 3.
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J Int Med Res. 2020 Apr;48(4):300060519887843. doi: 10.1177/0300060519887843. Epub 2019 Dec 29.