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中华胃肠内镜电子杂志 ›› 2019, Vol. 06 ›› Issue (04) : 145 -158. doi: 10.3877/cma.j.issn.2095-7157.2019.04.001

所属专题: 文献

共识与指南

国际专家组关于超声内镜引导下胰腺囊性肿瘤消融的立场声明
Anthony Yuen-Bun Teoh1, DongWan Seo2, William Brugge3, John Dewitt4, Pradermchai Kongkam5, Enqiang Linghu6(), Matthew T. Moyer7, Ji Kon Ry8, Khek Yu Ho9   
  1. 1. Anthony Yuen- Bun Teoh香港中文大学威尔斯亲王医院外科(中国香港)
    2. DongWanSeo牙山医学中心消化内科(韩国首尔市)
    3. William Brugge波士顿麻省总医院胃肠道胰胆道中心(美国马萨诸塞州)
    4. John Dewitt印第安纳波利斯的印第安纳大学医院消化内科(美国印第安纳州)
    5. PradermchaiKongkam朱拉隆功大学医学院医学系胰腺研究室和胃肠道内镜检查优秀中心,朱拉隆功纪念医院(泰国曼谷)
    6. EnqiangLinghu(令狐恩强)中国人民解放军总医院消化内科,(中国 北京)
    7. Matthew T. Moyer宾夕法尼亚州立大学好时医学中心胃肠病学和宾州州立大学癌症研究所(美国宾夕法尼亚州)
    8. JiKonRyu首尔国立大学医学院内科(韩国首尔)
    9. Khek Yu Ho新加坡国立大学医学院内科(新加坡)
  • 收稿日期:2019-10-18 出版日期:2019-11-15
  • 通信作者: Enqiang Linghu

Position statement on EUS-guided ablation of pancreatic cystic neoplasms from an international expert panel

Anthony Yuen-Bun Teoh1, DongWan Seo2, William Brugge3, John Dewitt4, Pradermchai Kongkam5, Enqiang Linghu6,(), Matthew T. Moyer7, Ji Kon Ry8, Khek Yu Ho9   

  1. 1. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong
    2. Department of Gastroenterology, Asan Medical Centre, Seoul, Korea
    3. Pancreas Biliary Center, Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts, United States
    4. Division of Gastroenterology, Department of Medicine, Indiana University Hospital, Indianapolis, Indiana, United States
    5. Pancreas Research Unit and Gastrointestinal EndoscopyExcellent Center, Department of Medicine, Faculty ofMedicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand
    6. Department of Gastroenterology, Chinese PLA General Hospital, Beijing, China
    7. Division of GI- Hepatology and Penn State UniversityCancer Institute, Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
    8. Department of Internal Medicine, Seoul NationalUniversity College of Medicine, Seoul, Korea
    9. Department of Medicine, National University ofSingapore, Singapore
  • Received:2019-10-18 Published:2019-11-15
  • Corresponding author: Enqiang Linghu
  • About author:
    Corresponding author: Enqiang Linghu, Email:
引用本文:

Anthony Yuen-Bun Teoh, DongWan Seo, William Brugge, John Dewitt, Pradermchai Kongkam, Enqiang Linghu, Matthew T. Moyer, Ji Kon Ry, Khek Yu Ho. 国际专家组关于超声内镜引导下胰腺囊性肿瘤消融的立场声明[J]. 中华胃肠内镜电子杂志, 2019, 06(04): 145-158.

Anthony Yuen-Bun Teoh, DongWan Seo, William Brugge, John Dewitt, Pradermchai Kongkam, Enqiang Linghu, Matthew T. Moyer, Ji Kon Ry, Khek Yu Ho. Position statement on EUS-guided ablation of pancreatic cystic neoplasms from an international expert panel[J]. Chinese Journal of Gastrointestinal Endoscopy(Electronic Edition), 2019, 06(04): 145-158.

背景和目的

最近,一些有关胰腺囊性肿瘤(pancreatic cystic neoplasms,PCNs)治疗的指南建议已经发表,但是超声内镜(endoscopic ultrasound,EUS)引导下PCNs消融的作用在这些指南中尚未明确。本文的目的是通过提出一系列临床问题并根据可获得的最佳科学证据提供答案来探讨围绕EUS引导下PCNs消融的问题。

方法

我们从亚洲EUS学组和一个国际专家组中招募了一个EUS引导下PCNs消融专家小组。创建了一个临床问题列表,并将每个问题分配给一个成员以产生一个陈述。然后在2016年10月至2017年10月的三次互联网会议上讨论了这些陈述。之后相互协商对这些陈述进行修改,直到取得协商一致意见。之后,将完整的陈述总结集体发送给所有小组成员,以对陈述的强度进行投票,对陈述进行分类,对证据进行分级。

结果

制定了关于EUS引导下PCNs的23个陈述。这些陈述涉及操作步骤、操作技术、操作前和操作后管理,并发症的管理以及手术中所需能力和培训。

结论

在所有内镜学会中,本共识是关于EUS引导下PCNs消融的首篇共识。有兴趣进行这项技术的临床医生应参考这些共识,未来的研究应设法解决本共识中提出的重要问题。

Objective

Background and aim Recently, several guidelines with divergent recommendations on management of pancreatic cystic neoplasm have been published but the role of endoscopic ultrasound (EUS)- guided pancreatic cyst ablation has not been thoroughly addressed. The aim of the current paper is to explore the issues surrounding EUS- guided pancreatic cyst ablation by generating a list of clinical questions and providing answers based on best scientific evidence available.

Methods

An expert panel in EUS- guided pancreatic cyst ablation was recruited from members of the Asian EUS group and an international expert panel. A list of clinical questions was created and each question allocated to one member to generate a statement in response. The statements were then discussed in three Internet conference meetings between October 2016 and October 2017. The statements were changed until consensus was obtained. Afterwards, the complete set of statements was sent to all the panelist to vote on strength of the statements, classification of the statement sand grading of the evidence.

Results

Twenty- three statements on EUS- guided drainage of pancreatic cyst ablation were formulated. The statements addressed indications for the procedures, technical aspects, pre- procedure and post- procedure management, management of complications, and competency and training in the procedures.

Conclusion

The current set of statements on EUS- guided pancreatic cyst ablation are the first to be published by any endoscopic society. Clinicians interested in developing the technique should reference these statements and future studies should address the key issues raised in the document.

表1 关于EUS引导的胰腺囊性肿瘤消融的陈述
编号 问题 陈述 陈述分类 证据质量
操作指征 ? ? ? ?
1 什么患者应进行PCNs消融? 对于那些不适合外科手术或拒绝接受手术的患者并且他们拥有相对乐观的寿命长度且至少有以下两种表现中的一种:单房或多房囊性肿瘤,推测或确诊为MCNs,直径> 2 cm且有增大趋势的PCNs或直径> 3 cm的PCNs。 B 中等
2 哪种大小和形状的PCNs对消融的反应最好? 直径2~6 cm的囊性肿瘤及囊内子囊≤6个的PCNs对消融反应最好。 B 中等
3 手术的禁忌证是什么? 绝对禁忌证:妊娠,严重凝血障碍,胰腺恶性肿瘤的迹象,活动性胰腺炎或胰腺坏死或预期寿命短。相对禁忌证:囊壁有可增强的壁结节,病变无或低恶性潜能,主胰管扩张>5 mm,与主胰管相通,PCNs内子囊数>6个,厚壁,粗大分隔,主胰管狭窄伴胰腺尾部萎缩,囊性肿瘤内有明显固体成分以及急性胰腺炎病史。 B 中等
4 术前需要什么程度的诊断确定性? 经治医师应准确确定囊性肿瘤是否为无恶性或低恶性的良性无症状PCNs。诊断其他类型的PCNs所需的治疗前检测程度在不同的医生中有所不同,需确保对患者进行恰当的诊断和制定合适的治疗计划。 B 中等操作准备
5 在进行EUS囊性肿瘤消融前需要进行哪些检查? 我们建议所有患者在消融前均应接受对胰腺增强CT、MRI、MRCP和/或EUS及EUS- FNA。术前应评估PCNs的解剖和形态特征,并可进行EUS- FNA进行生化和细胞学检查,以帮助诊断囊性肿瘤。 B 中等
6 是否需要预防性使用抗生素? 建议预防性使用抗生素(氟喹诺酮类或β-内酰胺类)预防术后感染。 C 中等
7 如果给予抗生素,需要持续多长时间? 如果使用抗生素,应持续3~5 d。 C 中等
操作注意点 ? ? ? ?
8 应该使用什么型号的穿刺针? 应该使用19G或22G针进行抽吸和注射。 B 中等
9 消融前是否应完全抽吸液体? 我们建议消融前在囊性肿瘤内的穿刺针周围留存少许液体。 C 很低
10 如果在EUS- FNA期间囊液粘性太大而无法抽出怎么办? 我们建议在高抽吸压力下使用19G针抽吸粘性液体。然后注射等量的生理盐水或乙醇以降低囊液的粘稠度。这个过程可以重复进行直至尽力抽吸出大部分囊液,便于后续消融操作重复该过程,以吸除大部分囊性肿瘤液进行消融。 C 很低
11 治疗的有效药物有哪些? 仅使用乙醇灌洗液、乙醇灌洗液后注入紫杉醇、无醇生理盐水灌洗液后加入紫杉醇-吉西他滨混合液、使用聚桂醇均有临床试验报道。 A
12 PCNs有效消融中乙醇是必须的吗? 乙醇是传统上用于消融的药物,然而,最近的两项试验表明,当使用化疗药物进行囊性肿瘤消融治疗时,乙醇消融剂不是必要的。 A
13 抽吸、灌洗和保留有什么区别?这些做法有什么不同吗? 抽吸是指用穿刺针吸取囊液。灌洗是反复抽吸和回注消融剂3~5 min。保留是指在改变患者体位的同时保留注射的乙醇20~40 min,特别是对于较大的囊性肿瘤。保留一段时间后,将注入的乙醇完全吸出。输注是指用消融剂(如紫杉醇或吉西他滨-紫杉醇)替代囊性肿瘤内容物,然后将保留在囊腔内。 C
EUS引导胰腺囊性肿瘤消融的效果 ? ? ? ?
14 术后应该如何判断治疗效果? 消融效果取决于囊性肿瘤体积的减少量(πr3),其中r是消融前和消融术后6个月随访时影像检查测量的囊性肿瘤半径。
完全缓解的定义为囊性肿瘤体积缩小至少95%。部分缓解是指囊性肿瘤体积缩小75%~95%,而无缓解则是指囊性肿瘤体积缩小<75%。胰腺囊性肿瘤消融后的变化通过形态和大小的变化来评估。消融前后的大小改变通常通过横断面成像进行预处理,然后在最后一次内镜消融后6个月和12个月进行评估[9,10,11]。理想情况下,每个患者术前术后的评估应采用相同的检查手段:胰腺CT或MRI或MRCP。
C 非常低
15 PCNs消融的效果如何? 仅使用无水乙醇的消融有效性为30%左右,乙醇灌洗后加入紫杉醇可使完全消融率提高到60%~79%。 A
16 消融对囊性肿瘤上皮有什么影响? 囊性肿瘤消融术后进行手术切除者较少,但是,有报道称内镜下治疗胰腺囊性肿瘤后组织上皮的改变率在0 ~100%之间,但通常在50%~100%之间。 C
17 手术后的细胞学和基因变化是什么? 有限的资料提示囊性肿瘤消融后基因学变化恢复正常。 C
随访和检测 ? ? ? ?
18 应该如何对这些患者进行术后随访和检测? 接受PCNs消融治疗并且后续未接受手术治疗的患者第一年应每隔6个月进行1次横断面影像学检查,然后每年1次,直到由于患者的年龄和医疗条件不再需要。这是为了监测消融效果和可能的不完全组织学消融后的复发情况。 B 中等
潜在的并发症和措施 ? ? ? ?
19 消融过程中潜在AEs是什么? 目前认为EUS引导下PCNs消融具有EUS- FNA相似的风险,而EUS- FNA被认为是安全的,很少发生AEs。与消融本身相关的特异性不良反应包括自限性腹痛、急性胰腺炎和静脉血栓栓塞。 A 中等
20 化学药物在消融过程中或之后有无全身效应? 用于PCNs消融的紫杉醇剂量已被证明是安全的,当注射入PCNs后,未检测出血药浓度。 B 中等
能力和培训 ? ? ? ?
21 谁应该学习消融术? EUS引导下PCNs消融术在技术上具有挑战性。按照管理该中心的相应国家协会的规定,实施该手术的医生应完成经认证的、标准化的介入性内镜培训计划。他们应该能够胜任EUS- FNA和EUS的介入治疗。 C
22 应如何进行EUS引导下消融治疗操作的培训? 只有完成了EUS和EUS- FNA培训并持有相应证书的医生才能进行PCNs消融。建议在有经验的医师的监督下完成5例消融以获得适当的经验,提升流利操作EUS的能力。 C 非常低
23 哪些中心应提供操作培训? 培训应该在病例量大的培训中心进行。该中心应拥有多学科团队,包括内镜专家、外科肿瘤学家和影像学专家,以便于讨论每个患者的情况和治疗策略。 B 非常低
表2 不同指南中胰腺囊性肿瘤的风险分层
表3 EUS引导乙醇消融联合或不联合紫杉醇和吉西他滨的研究汇总
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