中華醫(yī)學會消化內鏡學分會

中華醫(yī)學會消化內鏡學分會膠囊內鏡和小腸鏡學組于2008年制訂了《中華消化內鏡學會膠囊內鏡臨床應用規(guī)范》，對我國規(guī)范使用膠囊內鏡提供了有力參考。膠囊內鏡檢查歷經(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，尤其是對小腸疾病的診斷。隨著科學技術的不斷進步，除小腸膠囊內鏡出現(xiàn)部分改進外，食管專用膠囊內鏡、結腸專用膠囊內鏡以及專用磁控膠囊胃鏡亦已進入臨床應用階段。因此，膠囊內鏡和小腸鏡學組決定與時俱進，更新和完善相關規(guī)范，在經(jīng)過專家廣泛討論和多次修改后，現(xiàn)更新我國膠囊內鏡臨床應用指南如下。

一、檢查前準備、膠囊內鏡檢查

(一)檢查前準備

鑒于膠囊內鏡檢查可能發(fā)生膠囊滯留和診斷的不確定性，檢查前應對患者予以告知并簽署知情同意書。由于全國各地區(qū)膠囊內鏡檢查水平發(fā)展不均衡，現(xiàn)附統(tǒng)一知情同意書標準模板以規(guī)避可能出現(xiàn)的相關檢查風險(附錄一)。

小腸膠囊內鏡檢查[1-7]：

1. 檢查前需禁食或進清流質10～12 h；

2. 檢查前夜行腸道清潔準備(參考相關內鏡檢查腸道準備指南)；

3. 術前半小時服用適量祛泡劑，以減少泡沫對視野的影響；

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

食管專用膠囊內鏡檢查[8-9]：

1. 檢查前禁食2 h；

2. 飲用少量水(約10 mL)幫助膠囊內鏡吞服；

3. 檢查過程中患者取仰臥位，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。

結腸專用膠囊內鏡檢查[9-13]：

1. 檢查前1日進清流質飲食；

2. 檢查前夜行腸道清潔準備(參考相關內鏡檢查腸道準備指南)；

3. 檢查過程中加服小劑量磷酸鈉溶液(45～55 mL)，通過增加腸蠕動使膠囊盡早進入結腸(使用方法和禁忌證參照相關指南)；

4. 吞服膠囊后1 h膠囊尚未通過幽門者，建議給予促胃腸動力藥或經(jīng)胃鏡將膠囊送入十二指腸以縮短膠囊在胃內的停留時間。

胃專用膠囊內鏡檢查：

初步臨床研究結果顯示，對胃各部分顯示率達85%，診斷準確率為90%以上，有望在臨床推廣應用。

(二)膠囊內鏡檢查操作過程

檢查時將數(shù)據(jù)記錄儀通過導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，按時記錄相關癥狀并監(jiān)視數(shù)據(jù)記錄儀上閃爍的指示燈，以確定檢查設備的正常運行。檢查期間避免劇烈運動和進入強磁場區(qū)域，以防圖像信號受到干擾。服用膠囊2 h后可飲清水，4 h后可進少許清淡食物。在膠囊電池耗盡時或膠囊經(jīng)回盲瓣進入結腸(小腸膠囊內鏡)或自肛門排出體外(結腸膠囊內鏡)后將數(shù)據(jù)記錄儀從患者身上取下，并連接至可進行數(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，并由相關軟件進行處理。讀片中典型圖片和視頻可被單獨注釋和保存。工作站具有顯示膠囊走向軌跡的模擬定位功能，對幫助小腸內病灶的定位有一定參考意義。詳細檢查方法見相關產品說明書。

二、適應證和禁忌證

(一)小腸膠囊內鏡檢查主要適應證[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)測并指導克羅恩病治療；

4. 疑似小腸腫瘤；

5. 監(jiān)測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. 檢測非甾體消炎藥相關性小腸黏膜損害；

8. 臨床上需要排除小腸疾病者。

(二)食管專用膠囊內鏡檢查主要適應證[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. 需要接受食管內鏡檢查，但不愿接受或不能耐受胃食管鏡檢查者。

(三)結腸專用膠囊內鏡檢查主要適應證[9-10,12]

1. 需要接受結腸鏡檢查，但不能耐受或條件不允許者；

2. 結腸鏡檢查無法到達回盲瓣，同時無消化道梗阻者；

3. 潰瘍性結腸炎的隨訪，以指導治療；

4. 普通人群的結腸病變篩查。

(四)膠囊內鏡檢查禁忌證[9-13]

1. 絕對禁忌證：無手術條件或拒絕接受任何腹部手術者(一旦膠囊滯留將無法通過手術取出)；

2. 相對禁忌證：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、膠囊內鏡對疾病的診斷

(一)小腸膠囊內鏡

1. 不明原因消化道出血[14-30]：膠囊內鏡對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，顯性出血和隱性出血的診斷率分別為92%和44%，但對既往有出血史而近期無出血患者的診斷率僅為13%，因此膠囊內鏡的最佳檢查時機為出血剛停止數(shù)天至2周內。與術中小腸鏡的比較結果顯示膠囊內鏡對不明原因消化道出血診斷的敏感性、特異性、陽性預測值和陰性預測值分別為95%、75%、95%和86%。與氣囊式小腸鏡相比，總體診斷率相似，但膠囊內鏡對血管病變和炎癥性病灶更敏感且依從性更好，使膠囊內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。

最常見的小腸出血病因為血管病變，其次為克羅恩病和小腸腫瘤。

2. 小腸血管病變：包括小腸動靜脈畸形、毛細血管擴張癥、靜脈擴張癥等。主要表現(xiàn)為血管成叢簇樣，黏膜表面見局灶紅斑，血管分布錯亂，血管擴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]：膠囊內鏡可用于小腸克羅恩病的初次診斷、監(jiān)測疾病的復發(fā)、明確病變的范圍和嚴重程度、評估藥物、手術治療療效。膠囊內鏡對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、結腸鏡逆行回腸檢查。診斷敏感性可達90%。

克羅恩病的膠囊內鏡下表現(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是綜合性的，影像學檢查需與病史和其他檢查結合分析，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]：小腸腫瘤大多見于因其他指征而行膠囊內鏡的檢查中，盡管膠囊內鏡的發(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瘤、腺癌、類癌、黑色素瘤、淋巴瘤以及肉瘤等；良性腫瘤包括血管瘤、錯構瘤、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，結節(jié)或菜花狀，表面質脆易出血，部分呈潰瘍狀，病變邊界清晰可辨。

(2)小腸間質瘤：小腸間質瘤是最常見的小腸間葉來源腫瘤，占消化道間質瘤的30%，直徑<2 cm 被稱為小間質瘤。約30%的間質瘤表現(xiàn)出轉移、浸潤等惡性生物學行為；約1/3可合并出血。膠囊內鏡下小腸間質瘤主要表現(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，有時可見新鮮或陳舊血痂，部分可見裸露血管。

5. 遺傳性息肉病綜合征[43-48]：膠囊內鏡作為一項無創(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，尤其對直徑<5 mm的息肉更具優(yōu)勢。

對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說，由于需要定期隨訪和監(jiān)測，則膠囊內鏡更具優(yōu)勢。氣囊輔助式小腸鏡在檢出率方面優(yōu)于膠囊內鏡，但膠囊內鏡依從性更好。

6. 吸收不良綜合征(如乳糜瀉)[49]：膠囊內鏡下的特征性表現(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)狀皺襞消失以及結節(jié)樣改變等)以及與其并發(fā)癥相關的表現(xiàn)，如潰瘍性空腸炎、腸病相關性T細胞淋巴瘤、小腸腺癌等。膠囊內鏡診斷乳糜瀉的敏感性和特異性分別達到89%和95%。小腸吸收不良綜合征病因眾多，診斷應結合病史和血清學檢查等，小腸鏡下分段多點活檢有助于病理診斷，膠囊內鏡則有助于復雜乳糜瀉的診斷。

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

8. 其他[9]：膠囊內鏡還有助于一些少見小腸疾病的診斷，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；其次為結核、寄生蟲、放射性腸炎等。膠囊內鏡還可用于對胃腸動力障礙性疾病的研究、評估小腸移植術后的改變以及對不明原因腹痛和腹瀉的診斷等。

(二)食管專用膠囊內鏡[51-86]

食管專用膠囊內鏡診斷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%。以上結果均不及普通上消化道內鏡，其優(yōu)勢在于良好的依從性。

(三)結腸專用膠囊內鏡[87-112]

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

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

對于結直腸癌高危患者，結腸膠囊內鏡的特異性較高，但存在敏感性低和膠囊滯留增加的風險。因此，對于存在報警癥狀的結直腸癌高?；颊撸瑧邮艹Ｒ?guī)結直腸鏡檢查，結腸膠囊內鏡檢查不作為首選方法。

四、膠囊內鏡檢查的并發(fā)癥[113-120]

膠囊內鏡檢查的并發(fā)癥包括：膠囊滯留、誤吸入氣管等。

膠囊內鏡檢查后膠囊停留于胃腸道達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、腸結核以及手術吻合口狹窄等患者。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。滯留的膠囊可通過外科手術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致窒息的個案報道。對于已知或懷疑胃腸道梗阻、狹窄、瘺管者進行膠囊內鏡檢查需十分慎重，應在充分告知以及作好手術前準備的情況下完成檢查。

五、膠囊內鏡檢查的局限性

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

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

六、膠囊內鏡輔助輸送裝置

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

七、膠囊內鏡報告書寫的規(guī)范格式

膠囊內鏡標準報告書寫系統(tǒng)應由兩部分組成，即報告框架和報告內容。

(一)報告框架(基本資料和信息)

報告框架應盡可能按各單位習慣和相關專業(yè)指南標準設計，如：患者姓名、出生年月、性別、病例號、檢查日期、檢查類型(膠囊型號)、膠囊編號、操作醫(yī)師、病史、臨床指征、檢查范圍、病變描述、并發(fā)癥、檢查結果、診斷印象、建議等。

(二)報告內容

消化道黏膜有其顏色特征，包括紅斑、白色和蒼白等。每個病灶可由解剖位置或膠囊運行時間來定位，每種病變類型均作為一個單項進行觀察和描述，具體病變描述內容與標準內鏡相似。但由于對小腸病變的描述有其特殊性，建議參照膠囊內鏡標準術語使用規(guī)范(附錄二)。此外，還應注明膠囊工作時間以及通過食管、胃和小腸的時間。

八、膠囊內鏡標準術語使用規(guī)范(附錄二)

參與討論專家(按姓氏筆畫排序)：

戈之錚(上海交通大學醫(yī)學院附屬仁濟醫(yī)院消化科)、王邦茂(天津大學總醫(yī)院消化科)、厲有名(浙江大學附屬第一醫(yī)院消化科)、令狐恩強(中國人民解放軍總醫(yī)院消化科)、李兆申(第二軍醫(yī)大學附屬長海醫(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)大學附屬長海醫(yī)院消化科)、項平(復旦大學附屬華東醫(yī)院消化科)、趙曉晏(第三軍醫(yī)大學新橋醫(yī)院消化科)、鐘捷(上海交通大學醫(yī)學院附屬瑞金醫(yī)院消化科)、徐肇敏(南京大學醫(yī)學院附屬鼓樓醫(yī)院消化科)、智發(fā)朝(南方醫(yī)科大學南方醫(yī)院消化科)、廖專(第二軍醫(yī)大學附屬長海醫(yī)院消化科)

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