中國(guó)膠囊內(nèi)鏡臨床應(yīng)用指南

中華醫(yī)學(xué)會(huì)消化內(nèi)鏡學(xué)分會(huì)

中華醫(yī)學(xué)會(huì)消化內(nèi)鏡學(xué)分會(huì)膠囊內(nèi)鏡和小腸鏡學(xué)組于2008年制訂了《中華消化內(nèi)鏡學(xué)會(huì)膠囊內(nèi)鏡臨床應(yīng)用規(guī)范》，對(duì)我國(guó)規(guī)范使用膠囊內(nèi)鏡提供了有力參考。膠囊內(nèi)鏡檢查歷經(jīng)10余年的發(fā)展，已經(jīng)成為重要的消化道疾病檢查手段，尤其是對(duì)小腸疾病的診斷。隨著科學(xué)技術(shù)的不斷進(jìn)步，除小腸膠囊內(nèi)鏡出現(xiàn)部分改進(jìn)外，食管專(zhuān)用膠囊內(nèi)鏡、結(jié)腸專(zhuān)用膠囊內(nèi)鏡以及專(zhuān)用磁控膠囊胃鏡亦已進(jìn)入臨床應(yīng)用階段。因此，膠囊內(nèi)鏡和小腸鏡學(xué)組決定與時(shí)俱進(jìn)，更新和完善相關(guān)規(guī)范，在經(jīng)過(guò)專(zhuān)家廣泛討論和多次修改后，現(xiàn)更新我國(guó)膠囊內(nèi)鏡臨床應(yīng)用指南如下。

一、檢查前準(zhǔn)備、膠囊內(nèi)鏡檢查

(一)檢查前準(zhǔn)備

鑒于膠囊內(nèi)鏡檢查可能發(fā)生膠囊滯留和診斷的不確定性，檢查前應(yīng)對(duì)患者予以告知并簽署知情同意書(shū)。由于全國(guó)各地區(qū)膠囊內(nèi)鏡檢查水平發(fā)展不均衡，現(xiàn)附統(tǒng)一知情同意書(shū)標(biāo)準(zhǔn)模板以規(guī)避可能出現(xiàn)的相關(guān)檢查風(fēng)險(xiǎn)(附錄一)。

小腸膠囊內(nèi)鏡檢查[1-7]：

1. 檢查前需禁食或進(jìn)清流質(zhì)10～12 h；

2. 檢查前夜行腸道清潔準(zhǔn)備(參考相關(guān)內(nèi)鏡檢查腸道準(zhǔn)備指南)；

3. 術(shù)前半小時(shí)服用適量祛泡劑，以減少泡沫對(duì)視野的影響；

4. 不推薦使用促胃腸動(dòng)力藥。目前研究尚不支持促動(dòng)力藥能夠幫助提高全小腸檢查完成率。

食管專(zhuān)用膠囊內(nèi)鏡檢查[8-9]：

1. 檢查前禁食2 h；

2. 飲用少量水(約10 mL)幫助膠囊內(nèi)鏡吞服；

3. 檢查過(guò)程中患者取仰臥位，或可采用5分鐘法：吞服膠囊后2 min取仰臥位，繼2 min 30°半臥位，繼1 min 60°半臥位，繼以15 min坐位。

結(jié)腸專(zhuān)用膠囊內(nèi)鏡檢查[9-13]：

1. 檢查前1日進(jìn)清流質(zhì)飲食；

2. 檢查前夜行腸道清潔準(zhǔn)備(參考相關(guān)內(nèi)鏡檢查腸道準(zhǔn)備指南)；

3. 檢查過(guò)程中加服小劑量磷酸鈉溶液(45～55 mL)，通過(guò)增加腸蠕動(dòng)使膠囊盡早進(jìn)入結(jié)腸(使用方法和禁忌證參照相關(guān)指南)；

4. 吞服膠囊后1 h膠囊尚未通過(guò)幽門(mén)者，建議給予促胃腸動(dòng)力藥或經(jīng)胃鏡將膠囊送入十二指腸以縮短膠囊在胃內(nèi)的停留時(shí)間。

胃專(zhuān)用膠囊內(nèi)鏡檢查：

初步臨床研究結(jié)果顯示，對(duì)胃各部分顯示率達(dá)85%，診斷準(zhǔn)確率為90%以上，有望在臨床推廣應(yīng)用。

(二)膠囊內(nèi)鏡檢查操作過(guò)程

檢查時(shí)將數(shù)據(jù)記錄儀通過(guò)導(dǎo)線與粘貼于患者腹部體表的陣列傳感器電極相連或穿戴記錄儀背心?；颊咄谭z囊后，按時(shí)記錄相關(guān)癥狀并監(jiān)視數(shù)據(jù)記錄儀上閃爍的指示燈，以確定檢查設(shè)備的正常運(yùn)行。檢查期間避免劇烈運(yùn)動(dòng)和進(jìn)入強(qiáng)磁場(chǎng)區(qū)域，以防圖像信號(hào)受到干擾。服用膠囊2 h后可飲清水，4 h后可進(jìn)少許清淡食物。在膠囊電池耗盡時(shí)或膠囊經(jīng)回盲瓣進(jìn)入結(jié)腸(小腸膠囊內(nèi)鏡)或自肛門(mén)排出體外(結(jié)腸膠囊內(nèi)鏡)后將數(shù)據(jù)記錄儀從患者身上取下，并連接至可進(jìn)行數(shù)據(jù)處理的工作站。數(shù)據(jù)記錄儀中的圖像資料最終下載至工作站中，并由相關(guān)軟件進(jìn)行處理。讀片中典型圖片和視頻可被單獨(dú)注釋和保存。工作站具有顯示膠囊走向軌跡的模擬定位功能，對(duì)幫助小腸內(nèi)病灶的定位有一定參考意義。詳細(xì)檢查方法見(jiàn)相關(guān)產(chǎn)品說(shuō)明書(shū)。

二、適應(yīng)證和禁忌證

(一)小腸膠囊內(nèi)鏡檢查主要適應(yīng)證[9,11,13]

1. 不明原因消化道出血；

2. 不明原因缺鐵性貧血；

3. 疑似克羅恩病或監(jiān)測(cè)并指導(dǎo)克羅恩病治療；

4. 疑似小腸腫瘤；

5. 監(jiān)測(cè)小腸息肉病綜合征的發(fā)展；

6. 疑似或難以控制的吸收不良綜合征(如乳糜瀉等)；

7. 檢測(cè)非甾體消炎藥相關(guān)性小腸黏膜損害；

8. 臨床上需要排除小腸疾病者。

(二)食管專(zhuān)用膠囊內(nèi)鏡檢查主要適應(yīng)證[8-9,13]

1. 疑似Barrett食管；

2. 疑似食管炎；

3. 疑似食管靜脈曲張；

4. 需要接受食管內(nèi)鏡檢查，但不愿接受或不能耐受胃食管鏡檢查者。

(三)結(jié)腸專(zhuān)用膠囊內(nèi)鏡檢查主要適應(yīng)證[9-10,12]

1. 需要接受結(jié)腸鏡檢查，但不能耐受或條件不允許者；

2. 結(jié)腸鏡檢查無(wú)法到達(dá)回盲瓣，同時(shí)無(wú)消化道梗阻者；

3. 潰瘍性結(jié)腸炎的隨訪，以指導(dǎo)治療；

4. 普通人群的結(jié)腸病變篩查。

(四)膠囊內(nèi)鏡檢查禁忌證[9-13]

1. 絕對(duì)禁忌證：無(wú)手術(shù)條件或拒絕接受任何腹部手術(shù)者(一旦膠囊滯留將無(wú)法通過(guò)手術(shù)取出)；

2. 相對(duì)禁忌證：①已知或懷疑胃腸道梗阻、狹窄以及瘺管；②心臟起搏器或其他電子儀器植入者；③吞咽障礙者；④妊娠期婦女。

三、膠囊內(nèi)鏡對(duì)疾病的診斷

(一)小腸膠囊內(nèi)鏡

1. 不明原因消化道出血[14-30]：膠囊內(nèi)鏡對(duì)不明原因消化道出血的總體診斷率為35%～77%，出血診斷率的高低與出血狀況密切相關(guān)，顯性出血和隱性出血的診斷率分別為92%和44%，但對(duì)既往有出血史而近期無(wú)出血患者的診斷率僅為13%，因此膠囊內(nèi)鏡的最佳檢查時(shí)機(jī)為出血?jiǎng)偼Ｖ箶?shù)天至2周內(nèi)。與術(shù)中小腸鏡的比較結(jié)果顯示膠囊內(nèi)鏡對(duì)不明原因消化道出血診斷的敏感性、特異性、陽(yáng)性預(yù)測(cè)值和陰性預(yù)測(cè)值分別為95%、75%、95%和86%。與氣囊式小腸鏡相比，總體診斷率相似，但膠囊內(nèi)鏡對(duì)血管病變和炎癥性病灶更敏感且依從性更好，使膠囊內(nèi)鏡成為不明原因消化道出血的一線檢查手段，有助于臨床決策。

最常見(jiàn)的小腸出血病因?yàn)檠懿∽?，其次為克羅恩病和小腸腫瘤。

2. 小腸血管病變：包括小腸動(dòng)靜脈畸形、毛細(xì)血管擴(kuò)張癥、靜脈擴(kuò)張癥等。主要表現(xiàn)為血管成叢簇樣，黏膜表面見(jiàn)局灶紅斑，血管分布錯(cuò)亂，血管擴(kuò)張明顯高出黏膜面等。其主要臨床表現(xiàn)為不明原因消化道出血。

3. 克羅恩病[31-37]：膠囊內(nèi)鏡可用于小腸克羅恩病的初次診斷、監(jiān)測(cè)疾病的復(fù)發(fā)、明確病變的范圍和嚴(yán)重程度、評(píng)估藥物、手術(shù)治療療效。膠囊內(nèi)鏡對(duì)克羅恩病的診斷率為43%～77%，優(yōu)于小腸鋇灌、CT小腸重建、MRI小腸重建、結(jié)腸鏡逆行回腸檢查。診斷敏感性可達(dá)90%。

克羅恩病的膠囊內(nèi)鏡下表現(xiàn)主要為小腸絨毛缺失、黏膜充血水腫、黏膜糜爛、口瘡樣潰瘍、縱行潰瘍、卵石征、肉芽腫樣改變、腸管狹窄、瘺管、多發(fā)假性息肉等，病變多呈跳躍式分布。但克羅恩病的診斷應(yīng)是綜合性的，影像學(xué)檢查需與病史和其他檢查結(jié)合分析，部分患者可行氣囊輔助式小腸鏡輔以活檢病理等檢查予以佐證。

4. 小腸腫瘤[38-42]：小腸腫瘤大多見(jiàn)于因其他指征而行膠囊內(nèi)鏡的檢查中，盡管膠囊內(nèi)鏡的發(fā)現(xiàn)率高于CT檢查，但仍存在約19%的漏診率。最常見(jiàn)的臨床表現(xiàn)為不明原因消化道出血或貧血(占80%)。小腸惡性腫瘤包括間質(zhì)瘤、腺癌、類(lèi)癌、黑色素瘤、淋巴瘤以及肉瘤等；良性腫瘤包括血管瘤、錯(cuò)構(gòu)瘤、腺瘤等。

(1)小腸腺癌：小腸腺癌以位于十二指腸降段和Treitz韌帶附近居多，空、回腸相對(duì)較少。腺癌病灶常呈隆起增殖型，多伴腸腔狹窄，病灶表面高低不平，結(jié)節(jié)或菜花狀，表面質(zhì)脆易出血，部分呈潰瘍狀，病變邊界清晰可辨。

(2)小腸間質(zhì)瘤：小腸間質(zhì)瘤是最常見(jiàn)的小腸間葉來(lái)源腫瘤，占消化道間質(zhì)瘤的30%，直徑<2 cm 被稱(chēng)為小間質(zhì)瘤。約30%的間質(zhì)瘤表現(xiàn)出轉(zhuǎn)移、浸潤(rùn)等惡性生物學(xué)行為；約1/3可合并出血。膠囊內(nèi)鏡下小腸間質(zhì)瘤主要表現(xiàn)為隆起或半球狀，表面光滑，病灶中央可出現(xiàn)潰瘍或潰爛，有時(shí)可見(jiàn)新鮮或陳舊血痂，部分可見(jiàn)裸露血管。

5. 遺傳性息肉病綜合征[43-48]：膠囊內(nèi)鏡作為一項(xiàng)無(wú)創(chuàng)檢查，在非家族性腺瘤性息肉病、非Peutz-Jeghers綜合征患者中，息肉檢出率顯著高于MRI小腸重建，尤其對(duì)直徑<5 mm的息肉更具優(yōu)勢(shì)。

對(duì)于家族性腺瘤性息肉病和Peutz-Jeghers綜合征等遺傳性息肉病的患者來(lái)說(shuō)，由于需要定期隨訪和監(jiān)測(cè)，則膠囊內(nèi)鏡更具優(yōu)勢(shì)。氣囊輔助式小腸鏡在檢出率方面優(yōu)于膠囊內(nèi)鏡，但膠囊內(nèi)鏡依從性更好。

6. 吸收不良綜合征(如乳糜瀉)[49]：膠囊內(nèi)鏡下的特征性表現(xiàn)為小腸黏膜自身改變，即絨毛萎縮(扇貝樣、裂隙狀、馬賽克型、環(huán)狀皺襞消失以及結(jié)節(jié)樣改變等)以及與其并發(fā)癥相關(guān)的表現(xiàn)，如潰瘍性空腸炎、腸病相關(guān)性T細(xì)胞淋巴瘤、小腸腺癌等。膠囊內(nèi)鏡診斷乳糜瀉的敏感性和特異性分別達(dá)到89%和95%。小腸吸收不良綜合征病因眾多，診斷應(yīng)結(jié)合病史和血清學(xué)檢查等，小腸鏡下分段多點(diǎn)活檢有助于病理診斷，膠囊內(nèi)鏡則有助于復(fù)雜乳糜瀉的診斷。

7. 非甾體消炎藥相關(guān)性小腸黏膜損害[50]：研究顯示膠囊內(nèi)鏡對(duì)非甾體消炎藥相關(guān)性小腸黏膜受損的診斷率可高達(dá)68%。最常見(jiàn)的非甾體消炎藥相關(guān)性小腸黏膜病變?yōu)轲つて茡p、皺襞發(fā)紅、斑點(diǎn)狀黏膜出血、潰瘍以及腸隔膜形成等。

8. 其他[9]：膠囊內(nèi)鏡還有助于一些少見(jiàn)小腸疾病的診斷，如小腸憩室表現(xiàn)為黏膜上孔狀圓形洞穴，周邊黏膜光整柔軟，Meckel憩室通常表現(xiàn)為廣口或窄口的大憩室；其次為結(jié)核、寄生蟲(chóng)、放射性腸炎等。膠囊內(nèi)鏡還可用于對(duì)胃腸動(dòng)力障礙性疾病的研究、評(píng)估小腸移植術(shù)后的改變以及對(duì)不明原因腹痛和腹瀉的診斷等。

(二)食管專(zhuān)用膠囊內(nèi)鏡[51-86]

食管專(zhuān)用膠囊內(nèi)鏡診斷Barrett食管的敏感性約為77%，特異性約為86%；診斷食管炎的敏感性為50%～79%，特異性約為90%；診斷食管靜脈曲張的敏感性為82.7%，特異性為80.5%。以上結(jié)果均不及普通上消化道內(nèi)鏡，其優(yōu)勢(shì)在于良好的依從性。

(三)結(jié)腸專(zhuān)用膠囊內(nèi)鏡[87-112]

結(jié)腸專(zhuān)用膠囊內(nèi)鏡診斷明顯結(jié)腸病變(≥6 mm或≥3個(gè)獨(dú)立的息肉)的敏感性約為58%～86%。值得注意的是，膠囊內(nèi)鏡診斷息肉的特異性較低，容易高估小息肉的大小，但總體不影響結(jié)腸膠囊內(nèi)鏡對(duì)結(jié)腸息肉的篩查。

炎癥性腸病大多累及結(jié)直腸黏膜，約70%～80%的克羅恩病和幾乎全部的潰瘍性結(jié)腸炎可在結(jié)直腸發(fā)現(xiàn)病灶。目前研究表明，結(jié)腸膠囊內(nèi)鏡可用于監(jiān)測(cè)潰瘍性結(jié)腸炎的活動(dòng)性和評(píng)估療效。但目前尚無(wú)充足證據(jù)支持結(jié)腸膠囊內(nèi)鏡可用于確診可疑的炎癥性腸病，這部分患者仍應(yīng)選擇常規(guī)結(jié)腸鏡檢查。

對(duì)于結(jié)直腸癌高?；颊撸Y(jié)腸膠囊內(nèi)鏡的特異性較高，但存在敏感性低和膠囊滯留增加的風(fēng)險(xiǎn)。因此，對(duì)于存在報(bào)警癥狀的結(jié)直腸癌高?；颊撸瑧?yīng)接受常規(guī)結(jié)直腸鏡檢查，結(jié)腸膠囊內(nèi)鏡檢查不作為首選方法。

四、膠囊內(nèi)鏡檢查的并發(fā)癥[113-120]

膠囊內(nèi)鏡檢查的并發(fā)癥包括：膠囊滯留、誤吸入氣管等。

膠囊內(nèi)鏡檢查后膠囊停留于胃腸道達(dá)2周以上則定義為膠囊滯留。滯留主要發(fā)生于克羅恩病和易導(dǎo)致狹窄的高危疾病，如服用非甾體消炎藥、缺血性腸炎、小腸腫瘤、放射性腸炎、腸結(jié)核以及手術(shù)吻合口狹窄等患者。膠囊滯留的總體發(fā)生率為1.3%～1.4%，在不明原因消化道出血、克羅恩病、腫瘤性病變患者中，滯留率分別為1.2%、2.6%和2.1%。腹部X線攝片檢查能幫助確定膠囊是否排出。滯留的膠囊可通過(guò)外科手術(shù)和氣囊輔助式小腸鏡予以取出。有因膠囊滯留而造成腸道梗阻甚至穿孔以及因膠囊誤吸入氣管導(dǎo)致窒息的個(gè)案報(bào)道。對(duì)于已知或懷疑胃腸道梗阻、狹窄、瘺管者進(jìn)行膠囊內(nèi)鏡檢查需十分慎重，應(yīng)在充分告知以及作好手術(shù)前準(zhǔn)備的情況下完成檢查。

五、膠囊內(nèi)鏡檢查的局限性

目前無(wú)任何有關(guān)膠囊內(nèi)鏡造成電子設(shè)備(如心臟起搏器等)失效的報(bào)道[121-126]，但膠囊接近起搏器時(shí)存在內(nèi)鏡影像部分缺失的現(xiàn)象。在膠囊內(nèi)鏡檢查以及膠囊尚未排出體外時(shí)，不能接受MRI檢查。

非操控式膠囊的運(yùn)行依賴胃腸道的自身蠕動(dòng)，可能會(huì)影響膠囊觀察視角的精準(zhǔn)度，而非360°角度的視野可能存在拍攝盲區(qū)，易導(dǎo)致假陰性結(jié)果。

六、膠囊內(nèi)鏡輔助輸送裝置

多種附件可用于對(duì)吞咽困難、胃輕癱、已知或懷疑上消化道解剖結(jié)構(gòu)異常者的膠囊輸送，應(yīng)用外套管可將膠囊送入胃內(nèi)；應(yīng)用圈套器或網(wǎng)籃可將膠囊送入十二指腸和胃畢Ⅱ式手術(shù)后的輸出袢。輔助輸送裝置的臨床應(yīng)用將有助于完成特殊患者的膠囊內(nèi)鏡檢查[127]。

七、膠囊內(nèi)鏡報(bào)告書(shū)寫(xiě)的規(guī)范格式

膠囊內(nèi)鏡標(biāo)準(zhǔn)報(bào)告書(shū)寫(xiě)系統(tǒng)應(yīng)由兩部分組成，即報(bào)告框架和報(bào)告內(nèi)容。

(一)報(bào)告框架(基本資料和信息)

報(bào)告框架應(yīng)盡可能按各單位習(xí)慣和相關(guān)專(zhuān)業(yè)指南標(biāo)準(zhǔn)設(shè)計(jì)，如：患者姓名、出生年月、性別、病例號(hào)、檢查日期、檢查類(lèi)型(膠囊型號(hào))、膠囊編號(hào)、操作醫(yī)師、病史、臨床指征、檢查范圍、病變描述、并發(fā)癥、檢查結(jié)果、診斷印象、建議等。

(二)報(bào)告內(nèi)容

消化道黏膜有其顏色特征，包括紅斑、白色和蒼白等。每個(gè)病灶可由解剖位置或膠囊運(yùn)行時(shí)間來(lái)定位，每種病變類(lèi)型均作為一個(gè)單項(xiàng)進(jìn)行觀察和描述，具體病變描述內(nèi)容與標(biāo)準(zhǔn)內(nèi)鏡相似。但由于對(duì)小腸病變的描述有其特殊性，建議參照膠囊內(nèi)鏡標(biāo)準(zhǔn)術(shù)語(yǔ)使用規(guī)范(附錄二)。此外，還應(yīng)注明膠囊工作時(shí)間以及通過(guò)食管、胃和小腸的時(shí)間。

八、膠囊內(nèi)鏡標(biāo)準(zhǔn)術(shù)語(yǔ)使用規(guī)范(附錄二)

參與討論專(zhuān)家(按姓氏筆畫(huà)排序)：

戈之錚(上海交通大學(xué)醫(yī)學(xué)院附屬仁濟(jì)醫(yī)院消化科)、王邦茂(天津大學(xué)總醫(yī)院消化科)、厲有名(浙江大學(xué)附屬第一醫(yī)院消化科)、令狐恩強(qiáng)(中國(guó)人民解放軍總醫(yī)院消化科)、李兆申(第二軍醫(yī)大學(xué)附屬長(zhǎng)海醫(yī)院消化科)、陸星華(北京協(xié)和醫(yī)院消化科)、金震東(第二軍醫(yī)大學(xué)附屬長(zhǎng)海醫(yī)院消化科)、項(xiàng)平(復(fù)旦大學(xué)附屬華東醫(yī)院消化科)、趙曉晏(第三軍醫(yī)大學(xué)新橋醫(yī)院消化科)、鐘捷(上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院消化科)、徐肇敏(南京大學(xué)醫(yī)學(xué)院附屬鼓樓醫(yī)院消化科)、智發(fā)朝(南方醫(yī)科大學(xué)南方醫(yī)院消化科)、廖專(zhuān)(第二軍醫(yī)大學(xué)附屬長(zhǎng)海醫(yī)院消化科)

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