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      《腹腔鏡或機(jī)器人輔助胰腺癌根治術(shù)中國(guó)專家共識(shí)(2022年版)》解讀

      2024-01-01 00:00:00蔡志偉姜翀弋
      機(jī)器人外科學(xué) 2024年2期
      關(guān)鍵詞:機(jī)器人輔助手術(shù)腹腔鏡手術(shù)

      摘 要 《腹腔鏡或機(jī)器人輔助胰腺癌根治術(shù)中國(guó)專家共識(shí)(2022年版)》是由中國(guó)抗癌協(xié)會(huì)胰腺癌專業(yè)委員會(huì)微創(chuàng)診治學(xué)組與中華醫(yī)學(xué)會(huì)外科學(xué)分會(huì)胰腺外科學(xué)組組織全國(guó)部分胰腺外科專家制定,2022年首次發(fā)表于 Journal of Pancreatology。在此共識(shí)中,相關(guān)專家針對(duì)腹腔鏡或機(jī)器人輔助手術(shù)的安全性、腫瘤學(xué)獲益、學(xué)習(xí)曲線及挑戰(zhàn)性等方面做了詳細(xì)闡述,旨在為腹腔鏡或機(jī)器人輔助手術(shù)治療胰腺癌的臨床應(yīng)用提供參考與指導(dǎo)意見。

      關(guān)鍵詞 胰腺癌根治術(shù);腹腔鏡手術(shù);機(jī)器人輔助手術(shù);共識(shí)解讀

      中圖分類號(hào) R656 R735.9 文獻(xiàn)標(biāo)識(shí)碼 A 文章編號(hào) 2096-7721(2024)02-0299-05

      Interpretation of Chinese expert consensus on laparoscopic or robot-assisted radical pancreatectomy for pancreatic cancer (2022 edition)

      CAI Zhiwei, JIANG Chongyi

      (Department of General Surgery/Pancretobiliary Surgery Center, Huadong Hospital Affiliated to Fudan University,

      Shanghai 200040, China)

      Abstract Chinese expert consensus on laparoscopic or robot-assisted radical pancreatectomy for pancreatic cancer (2022 Edition) was first published in the Journal of Pancreatology in 2022. It is formulated by Study Group of Minimally Invasive Treatment for Pancreatic Cancer in China Anti-Cancer Association and Chinese pancreatic surgery association (CPSA), Chinese Society of Surgery, Chinese Medical Association referring to Chinese expert opinions and relevant researches in the world. This article is an interpretation of the consensus. The consensus addresses the safety, oncological benefits, learning curve, and challenging aspects of laparoscopic/robot-assisted surgery, providing a reference and guidance for the clinical application of laparoscopic/robot-assisted surgery in the treatment of pancreatic cancer.

      Key words Radical Resection of Pancreatic Cancer; Laparoscopic Surgery; Robot-assisted Surgery; Consensus Interpretation

      胰腺癌根治術(shù)因其較高的并發(fā)癥率和死亡率,被視為腹部外科中最具挑戰(zhàn)性的手術(shù)之一。微創(chuàng)手術(shù)已成為當(dāng)代外科學(xué)的主流趨勢(shì)。1994年,Gagner M等人[1]和Cuschieri A等人[2]相繼報(bào)道了首例保留幽門的腹腔鏡胰十二指腸切除術(shù)(Laparoscopic Pancreatoduodenectomy,LPD)和首例腹腔鏡胰體尾切除術(shù)(Laparoscopic Distal Pancreatectomy,LDP)。2000年,美國(guó)食品藥品監(jiān)督管理局批準(zhǔn)機(jī)器人手術(shù)系統(tǒng)在臨床中的應(yīng)用。隨后,Giulianotti P C等人[3]和Melvin W S等人[4]分別報(bào)道了首例機(jī)器人輔助胰十二指腸切除術(shù)(Robotic Pancreatoduodenectomy,RPD)和首例機(jī)器人輔助胰體尾切除術(shù)(Robotic Distal Pancreatectomy,RDP)。隨著腹腔鏡/機(jī)器人輔助外科手術(shù)技術(shù)的發(fā)展及手術(shù)器械的更新,其在胰腺癌領(lǐng)域的應(yīng)用日趨廣泛,從簡(jiǎn)單的探查活檢直至高難度的根治手術(shù)。然而,微創(chuàng)手術(shù)的安全性、腫瘤根治性、學(xué)習(xí)曲線以及復(fù)雜病例的手術(shù)方式選擇等問題仍有待商榷。鑒于胰腺癌有著較高的惡性生物學(xué)行為與較差的預(yù)后,有必要對(duì)腹腔鏡或機(jī)器人輔助下進(jìn)行胰腺癌根治手術(shù)的相關(guān)問題進(jìn)行探討并加以規(guī)范。因此,中國(guó)抗癌協(xié)會(huì)胰腺癌專業(yè)委員會(huì)微創(chuàng)診治學(xué)組與中華醫(yī)學(xué)會(huì)外科學(xué)分會(huì)胰腺外科學(xué)組組織國(guó)內(nèi)相關(guān)領(lǐng)域?qū)<腋鶕?jù)臨床實(shí)踐,并參考國(guó)內(nèi)外最新進(jìn)展發(fā)表了《腹腔鏡或機(jī)器人輔助胰腺癌根治術(shù)中國(guó)專家共識(shí)(2022年版)》。

      1 微創(chuàng)胰腺癌根治術(shù)的圍手術(shù)期安全性

      手術(shù)安全性是新技術(shù)得以順利開展的先決條件?;仡櫺匝芯勘砻?,雖然胰腺癌患者行LPD的手術(shù)時(shí)間略長(zhǎng)于開放手術(shù),但在總住院時(shí)間與術(shù)中出血量方面均優(yōu)于開放手術(shù),而在術(shù)后并發(fā)癥發(fā)生方面(如胰瘺、術(shù)后出血及圍手術(shù)期死亡率等)則無(wú)明顯差異[5]。一些回顧性研究和國(guó)內(nèi)最新發(fā)表的多中心傾向性評(píng)分匹配(Propensity Score Matching,PSM)分析RPD與開放胰十二指腸切除術(shù)(Open Pancreatoduodenectomy,OPD)也得到了相似的結(jié)論[6-8]。DIPLOMA研究是一項(xiàng)比較歐洲地區(qū)胰腺癌患者施行微創(chuàng)胰體尾切除術(shù)(Minimally Invasive Distal Pancreatectomy,MIDP)和開放胰體尾切除術(shù)(Open Distal Pancreatectomy,ODP)的大樣本回顧性研究,PSM處理后的結(jié)果表明MIDP手術(shù)組的術(shù)中出血量和住院時(shí)間均優(yōu)于ODP組,且兩組90 d內(nèi)死亡率無(wú)顯著差異[9]。隨后開展的前瞻性、多中心隨機(jī)研究(DIPLOMA)表明MIDP組的手術(shù)時(shí)間長(zhǎng)于ODP,而ICU住院時(shí)間顯著低于ODP,其它圍手術(shù)期相關(guān)并發(fā)癥和90 d內(nèi)死亡率等均無(wú)顯著差異[10]。因此,從現(xiàn)有研究結(jié)果來(lái)看,微創(chuàng)胰腺癌根治手術(shù)在圍手術(shù)期安全性方面不劣于開放手術(shù),且具有潛在優(yōu)勢(shì)。在具備相應(yīng)技術(shù)條件的單位可以安全開展相關(guān)手術(shù)。

      2 微創(chuàng)胰腺癌根治術(shù)的腫瘤學(xué)獲益

      無(wú)論腹腔鏡手術(shù)還是機(jī)器人輔助手術(shù),均是胰腺癌綜合治療環(huán)節(jié)中的一個(gè)技術(shù)手段,腫瘤學(xué)根治效果是判斷其能否勝任胰腺癌治療的關(guān)鍵?;仡櫺匝芯匡@示,LPD較OPD在R0切除率、淋巴結(jié)獲取數(shù)量方面具有一定優(yōu)勢(shì)[11-12],Meta分析結(jié)果同樣顯示LPD不劣于OPD的腫瘤學(xué)根治效果[13],甚至在無(wú)病生存期和總生存期方面有優(yōu)于OPD的趨勢(shì)[14]。分析美國(guó)國(guó)家癌癥數(shù)據(jù)庫(kù)(National Cancer Database,NCDB)中的數(shù)據(jù),比較RPD、LPD與OPD三者的腫瘤根治效果,發(fā)現(xiàn)在淋巴結(jié)獲取數(shù)量與術(shù)后輔助化療率方面RPD與LPD相當(dāng),且均優(yōu)于OPD;在R0切除率與遠(yuǎn)期預(yù)后方面,三者相比無(wú)顯著差異[15-16]??紤]到微創(chuàng)胰十二指腸切除術(shù)(Minimally Invasive Pancreatoduodenectomy,MIPD)不劣于OPD的腫瘤根治效果,以及微創(chuàng)手術(shù)后的快速康復(fù)有利于患者能夠盡早接受術(shù)后輔助治療,因此,MIPD較OPD可能存在潛在的生存獲益。但回顧性研究不可避免地會(huì)存在選擇性偏倚,目前又缺乏高質(zhì)量的循證學(xué)證據(jù),因此仍需前瞻性隨機(jī)隊(duì)列研究提供更可靠數(shù)據(jù)支持??傮w而言,對(duì)于經(jīng)過術(shù)前篩選的胰腺癌病例,MIPD可獲得不劣于OPD的腫瘤學(xué)根治效果。在技術(shù)成熟的單位,MIPD下實(shí)現(xiàn)手術(shù)區(qū)域的血管裸化或動(dòng)脈鞘剝離以及海德堡三角的徹底清掃已成為常規(guī)的手術(shù)操作。因此各單位結(jié)合各自經(jīng)驗(yàn)選擇合適的胰腺癌病例開展RPD或LPD手術(shù)能夠保證腫瘤根治效果。

      回顧性研究顯示LDP與ODP在R0切除率、淋巴結(jié)清掃數(shù)量、化療完成率、術(shù)后復(fù)查率及總體生存期等方面均無(wú)顯著差異[17-18]。比較RDP與ODP的單中心回顧性研究同樣未發(fā)現(xiàn)兩者之間在腫瘤學(xué)根治與遠(yuǎn)期預(yù)后之間的統(tǒng)計(jì)學(xué)差異[16,19-21]。最新發(fā)表的前瞻性DIPLOMA研究顯示:MIDP組的R0切除率不劣于ODP組,且在淋巴結(jié)清掃數(shù)量、總生存時(shí)間和無(wú)復(fù)發(fā)生存時(shí)間等方面無(wú)顯著差異[10]。相比于傳統(tǒng)術(shù)式,根治性順行模塊化胰脾切除術(shù)(Radical Antegrade Modular Pancreatosplenectomy,RAMPS)強(qiáng)調(diào)保證后腹膜切緣的陰性。Meta分析顯示,胰體尾癌患者行腹腔鏡RAMPS較傳統(tǒng)手術(shù)可提高R0切除率和淋巴結(jié)獲取數(shù)量[22]。總體而言,MIDP與ODP的腫瘤學(xué)根治效果及遠(yuǎn)期生存率相當(dāng),且MIDP手術(shù)的技術(shù)難度較MIPD為低,因此MIDP存在更為廣泛的開展基礎(chǔ)。

      3 微創(chuàng)胰腺癌根治術(shù)的學(xué)習(xí)曲線

      鑒于微創(chuàng)胰腺手術(shù)的復(fù)雜性,共識(shí)特別強(qiáng)調(diào)了胰腺癌微創(chuàng)手術(shù)的學(xué)習(xí)曲線問題。多數(shù)學(xué)者認(rèn)為L(zhǎng)PD的學(xué)習(xí)曲線在30~40例。度過學(xué)習(xí)曲線后,手術(shù)時(shí)間、術(shù)中出血量及術(shù)后嚴(yán)重并發(fā)癥發(fā)生率等方面可明顯下降[23-25]。LEOPARD-2研究的中期結(jié)果顯示LPD組90 d死亡率是OPD組的5倍,其重要原因就是參與研究的術(shù)者未能完全度過學(xué)習(xí)曲線[26]。其次,要重視度過學(xué)習(xí)曲線之后挑戰(zhàn)期的存在。術(shù)者在度過最初的學(xué)習(xí)曲線階段后一般會(huì)選擇難度較高的病例,雖然已經(jīng)度過學(xué)習(xí)曲線,但并發(fā)癥發(fā)生率有時(shí)并未明顯改善[25]。研究認(rèn)為在完成104例手術(shù)后才能完全度過挑戰(zhàn)期[23]。多數(shù)文獻(xiàn)報(bào)道RPD的學(xué)習(xí)曲線也是30~40例[27-28]。由于RPD操作更符合開放手術(shù)習(xí)慣,在度過學(xué)習(xí)曲線前,RPD較LPD可能具有更多的圍手術(shù)期安全性優(yōu)勢(shì)。隨著腹腔鏡/機(jī)器人輔助胰腺癌根治手術(shù)技術(shù)的不斷發(fā)展,“鉤突系膜薄層化”“原位切除”等有別于傳統(tǒng)開放手術(shù)的微創(chuàng)手術(shù)入路已逐漸成熟[29-30],第二、三代外科醫(yī)師在第一代外科醫(yī)師的指導(dǎo)下開展該手術(shù)時(shí),其學(xué)習(xí)曲線有望大幅縮短[31]。

      中轉(zhuǎn)開放是開展微創(chuàng)胰腺癌根治手術(shù)時(shí)不可避免的問題,尤其在學(xué)習(xí)曲線的早期階段。目前認(rèn)為MIPD中轉(zhuǎn)的危險(xiǎn)因素有:腫瘤最大直徑gt;4 cm、患者年齡gt;75歲、腹腔鏡輔助手術(shù)以及在低通量醫(yī)學(xué)中心接受手術(shù)[32];MIDP中轉(zhuǎn)開放的危險(xiǎn)因素則為腫瘤距離脾血管根部lt;1 cm[33]。因此,共識(shí)中強(qiáng)調(diào),在度過學(xué)習(xí)曲線之前,應(yīng)謹(jǐn)慎選擇病例,盡量避免嘗試具有中轉(zhuǎn)開放危險(xiǎn)因素的胰腺癌病例。但手術(shù)中轉(zhuǎn)并不意味著微創(chuàng)手術(shù)的失敗,而是術(shù)者根據(jù)術(shù)中實(shí)際情況做出的手術(shù)策略改變。

      4 開展高難度微創(chuàng)胰腺癌手術(shù)面臨的挑戰(zhàn)

      近年來(lái),新輔助治療是胰腺癌治療領(lǐng)域中具有重要意義的里程碑事件。研究發(fā)現(xiàn),新輔助治療可提高腫瘤的R0切除率,降低淋巴結(jié)轉(zhuǎn)移率,減少神經(jīng)和血管浸潤(rùn),并延長(zhǎng)患者生存期[34]。然而,新輔助治療引起的胰腺炎癥水腫與纖維化粘連也增加了手術(shù)難度,可能導(dǎo)致手術(shù)相關(guān)并發(fā)癥發(fā)生率的上升。目前關(guān)于新輔助后行微創(chuàng)胰腺癌根治術(shù)安全性和有效性的數(shù)據(jù)稀缺。Nassour I等人[35]對(duì)NCDB中接受新輔助化療的胰腺癌患者進(jìn)行回顧性分析,發(fā)現(xiàn)與OPD組相比,RPD組患者住院時(shí)間更短、清掃淋巴結(jié)數(shù)量更多,且接受術(shù)后輔助化療的比例更高,兩組患者在圍手術(shù)期死亡率和遠(yuǎn)期生存率方面則無(wú)顯著差異。因此,本共識(shí)推薦在微創(chuàng)胰腺手術(shù)經(jīng)驗(yàn)豐富的單位,可以開展新輔助治療后微創(chuàng)根治手術(shù)的探索。

      隨著技術(shù)的進(jìn)步,聯(lián)合門靜脈-腸系膜上靜脈切除重建的MIPD已在國(guó)內(nèi)外部分中心得到開展。單中心的回顧性研究顯示該手術(shù)并發(fā)癥發(fā)生率與開放組相比無(wú)顯著差異,該手術(shù)是安全可行的[36-37]。但最近發(fā)表的多中心研究則有不同結(jié)論[38]。因此,聯(lián)合血管切除的MIPD手術(shù)應(yīng)僅在大型胰腺外科中心,且由經(jīng)驗(yàn)豐富的胰腺微創(chuàng)外科醫(yī)師開展。

      5 總結(jié)與展望

      腹腔鏡/機(jī)器人輔助胰腺癌根治術(shù)的圍手術(shù)期安全性與腫瘤根治效果已得到初步證實(shí)。隨著手術(shù)技術(shù)的推廣普及,腹腔鏡/機(jī)器人輔助手術(shù)的應(yīng)用將日趨廣泛。雖然微創(chuàng)技術(shù)能給患者帶來(lái)一定的獲益,但其仍只是胰腺癌綜合治療中的一種手段,應(yīng)嚴(yán)格把握手術(shù)適應(yīng)證,謹(jǐn)慎挑選患者,切忌“為微創(chuàng)而微創(chuàng)”。對(duì)于接受新輔助治療后或需行血管切除重建等復(fù)雜手術(shù)的病例,應(yīng)在完全度過學(xué)習(xí)曲線后選擇性開展。隨著國(guó)內(nèi)外胰腺中心開展更多的前瞻性隨機(jī)對(duì)照研究,未來(lái)有望提供更多高質(zhì)量的研究證據(jù)以規(guī)范和推動(dòng)腹腔鏡/機(jī)器人輔助技術(shù)在胰腺癌根治術(shù)中的應(yīng)用。

      利益沖突聲明:本文不存在任何利益沖突。

      作者貢獻(xiàn)聲明:①蔡志偉負(fù)責(zé)設(shè)計(jì)論文框架,起草論文;②姜翀弋負(fù)責(zé)擬定寫作思路,指導(dǎo)撰寫文章并最后定稿。

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      編輯:魏小艷

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