本文選題：肝內(nèi)膽管細(xì)胞癌 + 根治性切除手術(shù)��； 參考：《第二軍醫(yī)大學(xué)》2017年碩士論文

【摘要】：研究背景和目的肝內(nèi)膽管細(xì)胞癌(Intrahepatic cholangiocarcinoma ICC),是來源于肝內(nèi)膽管二級分支及以上的惡性腫瘤,既往將其與原發(fā)性肝細(xì)胞癌(Hepatocellular carcinoma HCC)認(rèn)作為原發(fā)性肝癌的兩種類型。然而現(xiàn)在越來越多的研究發(fā)現(xiàn),ICC從發(fā)生來源、生長方式、浸潤傾向、轉(zhuǎn)移特點(diǎn)、影像學(xué)表現(xiàn)、治療及預(yù)后上與原發(fā)性肝細(xì)胞癌都存在較大的差異,因而目前傾向于對ICC進(jìn)行獨(dú)立研究。AJCC(American Joint Committee On Cancer)7版已經(jīng)將ICC進(jìn)行了獨(dú)立的TNM分期,關(guān)于ICC預(yù)后預(yù)判的獨(dú)立模型也已有初步的探索研究,這些都符合將其作為一種獨(dú)立疾病的認(rèn)識。目前ICC的主要治療方式包括:手術(shù)切除、局部治療、全身化療、放射治療。其中手術(shù)治療的方式包括:根治性的開腹手術(shù)切除、腹腔鏡手術(shù)切除;局部治療的方式包括:肝動脈化療栓塞術(shù)(Transarterial chemoembolization TACE)、射頻消融術(shù)(Radiofrequency ablation RFA)和微波消融術(shù)(Microwave ablation MWA),其中腹腔鏡同時(shí)可用于探查和輔助診斷。由于ICC對放療及全身化療敏感性不高,因而放化療常作為晚期失去手術(shù)機(jī)會或復(fù)發(fā)不可再手術(shù)患者的輔助治療或姑息性治療手段。根治性手術(shù)切除則是目前公認(rèn)的能夠改善預(yù)后,取得較好效果的外科治療方式。但值得注意的是,與HCC不同,ICC發(fā)生肝臟周圍區(qū)域淋巴結(jié)轉(zhuǎn)移的傾向性十分明顯。大量研究報(bào)道,淋巴結(jié)轉(zhuǎn)移是引起ICC患者術(shù)后早期復(fù)發(fā)與轉(zhuǎn)移,影響長期生存最重要的獨(dú)立危險(xiǎn)因素。因而,若術(shù)前評估腫瘤可以被根治性切除,同時(shí)淋巴結(jié)無轉(zhuǎn)移證據(jù)的患者是可能從根治性手術(shù)治療中獲益的。然而目前的術(shù)前檢查手段當(dāng)中,并沒有對淋巴結(jié)轉(zhuǎn)移診斷具有高準(zhǔn)確度和敏感度的方法,所以ICC的根治性手術(shù)治療過程中除腫瘤本身的切除以外,相關(guān)區(qū)域內(nèi)淋巴結(jié)情況的探查和清掃切除越來越得到外科領(lǐng)域的重視。在目前研究過程中逐漸認(rèn)識到,淋巴結(jié)的腫大原因多樣,炎癥、腫瘤轉(zhuǎn)移均可導(dǎo)致,但含腫瘤細(xì)胞的淋巴結(jié)卻不一定完全呈腫大狀態(tài),所以根據(jù)術(shù)中經(jīng)驗(yàn)性探查結(jié)果來決定是否進(jìn)行淋巴結(jié)的摘除活檢或清掃似乎并不可靠,可能存在遺留含腫瘤轉(zhuǎn)移的淋巴結(jié)于患者體內(nèi)的風(fēng)險(xiǎn)。常規(guī)進(jìn)行術(shù)中淋巴結(jié)清掃似乎更為穩(wěn)妥,目前有研究認(rèn)為,其能夠?yàn)轭A(yù)后判斷、疾病分期提供有價(jià)值的信息,但爭議點(diǎn)在于積極的常規(guī)淋巴結(jié)清掃是否能確實(shí)改善患者預(yù)后,使患者獲益。所以對于術(shù)前評估可行根治性切除(R0切除)的ICC患者,是否應(yīng)在手術(shù)中常規(guī)進(jìn)行淋巴結(jié)清掃值得進(jìn)一步研究。為此本研究對行R0切除的ICC患者進(jìn)行了回顧性分析研究,觀察與該類患者預(yù)后生存相關(guān)的影響因素(包括淋巴結(jié)轉(zhuǎn)移在患者術(shù)后腫瘤復(fù)發(fā)和生存中的影響作用),分析術(shù)中行淋巴結(jié)清掃對患者預(yù)后的影響,分析與淋巴結(jié)轉(zhuǎn)移相關(guān)的影響因素,主要探究常規(guī)淋巴結(jié)清掃是否具有臨床意義。研究方法本研究回顧性收集2010年1月至2015年12月在第二軍醫(yī)大學(xué)附屬東方肝膽外科醫(yī)院診斷為肝內(nèi)膽管細(xì)胞癌(ICC),并接受手術(shù)治療的患者病例。納入標(biāo)準(zhǔn):(1)術(shù)前檢查無明確淋巴結(jié)轉(zhuǎn)移證據(jù),肝內(nèi)病灶行根治性切除者(2)術(shù)后病理證實(shí)為ICC者(3)術(shù)中探查發(fā)現(xiàn)可疑淋巴結(jié),則進(jìn)行淋巴結(jié)清掃者。剔除標(biāo)準(zhǔn):(1)非根治性切除者(姑息性切除或術(shù)后病理切緣陽性患者)(2)僅行可疑淋巴結(jié)摘除活檢者(3)病例資料缺失及失訪者。(4)死亡原因與疾病本身無關(guān)者。最終納入患者265例(132例行術(shù)中淋巴結(jié)清掃)。根治性切除定義:完整切除肝內(nèi)腫瘤病灶,術(shù)后病理證實(shí)肝內(nèi)腫瘤病灶切緣陰性,術(shù)中探查淋巴結(jié)可疑則行淋巴結(jié)清掃。淋巴結(jié)清掃范圍定義:至少包括肝動脈周圍、肝十二指腸韌帶內(nèi)淋巴結(jié),可包括肝胃韌帶內(nèi)、胰頭周圍淋巴結(jié)。收集納入病例的術(shù)前臨床資料(性別、年齡、乙肝病史、丙肝病史、膽道術(shù)史、糖尿病史、高血壓病史、術(shù)前AFP水平、術(shù)前CEA水平、術(shù)前CA-199水平、術(shù)前TB值、術(shù)前ALT值等);術(shù)中情況(腫瘤大小、腫瘤周邊子灶有無、血管侵犯有無、肝門阻斷時(shí)間、術(shù)中出血量等)以及術(shù)后病理資料(腫瘤定性、腫瘤分化程度、腫瘤切緣狀態(tài)、淋巴結(jié)病理結(jié)果)以及患者術(shù)后隨訪資料。主要采用Cox單因素分析法對預(yù)后影響因素進(jìn)行單因素分析,以P0.05為標(biāo)準(zhǔn),具統(tǒng)計(jì)學(xué)意義因素納入多因素分析,風(fēng)險(xiǎn)比(HR)表達(dá)其為危險(xiǎn)或保護(hù)因素。采用Kaplan-Meier生存分析法及傾向性配對分析法(PSM),分析術(shù)后生存情況并繪制相關(guān)生存曲線,采用log-rank法校驗(yàn)生存率,P0.05為差異有統(tǒng)計(jì)學(xué)意義。采用卡方檢驗(yàn)分析術(shù)后并發(fā)癥差異,P0.05為差異有統(tǒng)計(jì)學(xué)意義。采用logistic回歸分析法分析淋巴結(jié)轉(zhuǎn)移相關(guān)影響因素,P0.05為差異有統(tǒng)計(jì)學(xué)意義。研究結(jié)果截至2015年12月,在265例患者中,觀察到復(fù)發(fā)及轉(zhuǎn)移者共196例(74.0%),死亡151例(57.0%),中位隨訪時(shí)間33.5個(gè)月。全部患者1、2、3年無瘤生存率:50%、29%、20%,中位無瘤生存時(shí)間11.9個(gè)月;1、2、3年總生存率77%、47%、36%,總中位生存時(shí)間22.8個(gè)月。對預(yù)后影響因素進(jìn)行Cox多因素分析的研究結(jié)果顯示,影響患者無瘤生存的因素有:糖尿病史(P=0.03,HR 1.626)、術(shù)前CA-199高水平(P=0.002,HR 1.001)、腫瘤直徑≥5cm(P=0.034,HR 1.410)、腫瘤周邊子灶(P=0.012,HR 1.617)、淋巴結(jié)清掃(P=0.001;HR 0.451);影響患者總體生存的因素有:術(shù)前CA-199高水平(P=0.015,HR 1.001)、腫瘤直徑≥5cm(P=0.009,HR 1.639)、血管侵犯(P=0.007;HR 2.526)、淋巴結(jié)清掃(P=0.001;HR 0.396)。分組對比結(jié)果:(一)PSM前:清掃組132例(復(fù)發(fā)轉(zhuǎn)移患者79例,占該組59.8%,占總體29.8%,淋巴結(jié)病理診斷陽性者52例),未清掃組133例(復(fù)發(fā)轉(zhuǎn)移患者117例,占該組87.9%,占總體44.2%)。(1)無瘤生存情況比較:1、2、3年無瘤生存率:清掃組65%、41%、30%,未清掃組36%、18%、12%,(P=0.001),中位無瘤生存時(shí)間:清掃組18.0個(gè)月,未清掃組9.0個(gè)月;(2)總體生存情況比較:1、2、3年總生存率:清掃組86%、66%、51%,未清掃組69%、32%、24%,(P=0.001)。中位總生存時(shí)間:清掃組42.0個(gè)月,未清掃組17.0個(gè)月。(二)PSM后:清掃組77例,未清掃組77例。(1)無瘤生存情況比較:1、2、3年無瘤生存率:清掃組68%、47%、36%,未清掃組31%、13%、6%,(P=0.001),中位無瘤生存時(shí)間:清掃組22.2個(gè)月,未清掃組9.2個(gè)月;(2)總體生存情況比較:1、2、3年總生存率:清掃組91%、75%、56%,未清掃組71%、30%、21%,(P=0.001)。中位總生存時(shí)間:清掃組46.8個(gè)月,未清掃組17.0個(gè)月。剔除清掃組淋巴結(jié)陽性患者,比較清掃組中淋巴結(jié)病理診斷陰性與未清掃患者生存情況:(一)PSM前:清掃淋巴結(jié)陰性組80例,未清掃組133例。(1)無瘤生存情況:1、2、3年無瘤生存率:清掃淋巴結(jié)陰性組76%、56%、44%,未清掃組患者36%、18%、12%,(P=0.001)。中位無瘤生存時(shí)間:清掃淋巴結(jié)陰性組27.9個(gè)月,未清掃組9.0個(gè)月。(2)總體生存情況比較:1、2、3年總生存率:清掃淋巴結(jié)陰性組95%、78%、65%,未清掃組69%、32%、24%,(P=0.001)。中位總生存時(shí)間:清掃淋巴結(jié)陰性組48.0個(gè)月,未清掃組17.0個(gè)月。(3)術(shù)后并發(fā)癥情況比較無統(tǒng)計(jì)學(xué)意義。(二)PSM后:清掃淋巴結(jié)陰性組50例,未清掃組50例。(1)無瘤生存情況比較:1、2、3年無瘤生存率:清掃淋巴結(jié)陰性組77%、60%、52%,未清掃組32%、22%、15%,(P=0.001),中位無瘤生存時(shí)間:清掃淋巴結(jié)陰性組38.1個(gè)月,未清掃組9.0個(gè)月;(2)總體生存情況比較:1、2、3年總生存率:清掃淋巴結(jié)陰性組94%、82%、74%,未清掃組68%、40%、28%,(P=0.001)。中位總生存時(shí)間:清掃淋巴結(jié)陰性組54.0個(gè)月,未清掃組18.9個(gè)月�；颊吡馨徒Y(jié)轉(zhuǎn)移影響因素的分析中,腫瘤直徑≥5cm(P=0.012,HR 1.859)、術(shù)前CA-199高水平(P=0.002,HR 2.415)是影響患者淋巴結(jié)轉(zhuǎn)移的獨(dú)立危險(xiǎn)因素。研究結(jié)論1.對于接受R0切除的ICC患者,糖尿病史、術(shù)前CA-199高水平、腫瘤直徑≥5cm、腫瘤伴有子灶是影響患者無瘤生存的獨(dú)立危險(xiǎn)因素;術(shù)前CA-199高水平、腫瘤直徑≥5cm、血管侵犯是影響患者總生存的獨(dú)立危險(xiǎn)因素。2.術(shù)中行淋巴結(jié)清掃是接受R0切除的ICC患者術(shù)后生存的保護(hù)因素。3.分組比較的研究結(jié)果顯示,行淋巴結(jié)清掃可使患者預(yù)后得到改善。4.術(shù)前CA-199高水平、腫瘤直徑≥5cm是ICC患者發(fā)生淋巴結(jié)轉(zhuǎn)移的獨(dú)立危險(xiǎn)因素。術(shù)中淋巴結(jié)清掃可以改善ICC患者預(yù)后,同時(shí)獲得淋巴結(jié)病理有助于對患者的預(yù)后判斷及術(shù)后輔助治療策略的制定。術(shù)前診斷無明確淋巴結(jié)轉(zhuǎn)移證據(jù),評估可根治性切除的ICC患者,尤其是術(shù)前CA-199水平較高、腫瘤直徑較大的患者在手術(shù)過程中應(yīng)積極常規(guī)進(jìn)行淋巴結(jié)清掃。
[Abstract]:Background and objective Intrahepatic cholangiocarcinoma ICC (ICC), which is a malignant tumor derived from the two branches of the intrahepatic bile duct and above, has previously identified the two types of primary hepatocellular carcinoma (Hepatocellular carcinoma HCC) as primary liver cancer. However, more and more studies have found that ICC has occurred. Sources, growth patterns, infiltration tendencies, metastasis characteristics, imaging manifestations, treatment and prognosis are very different from primary hepatocellular carcinoma, so the independent study on.AJCC (American Joint Committee On Cancer) 7 version 7 has been independent TNM staging of ICC, and independent model of prognostic prediction for ICC is also available. There are preliminary exploratory studies that meet the understanding of an independent disease. The main treatments for ICC include surgical resection, local treatment, systemic chemotherapy, radiation therapy. Surgical treatment includes radical open surgery, abdominal hysterectomy, and local treatment of hepatic arteriolarization. Transarterial chemoembolization TACE (TACE), radiofrequency ablation (Radiofrequency ablation RFA) and microwave ablation (Microwave ablation MWA), which can be used for exploration and auxiliary diagnosis. Because ICC is not sensitive to radiotherapy and systemic chemotherapy, chemoradiotherapy often acts as a late loss of operation or relapse. Adjuvant therapy or palliative treatment of reoperative patients. Radical resection is now recognized as a surgical approach to improve the prognosis and achieve better results. However, it is worth noting that, unlike HCC, the tendency of ICC to develop lymph node metastases around the liver is obvious. A large number of studies have reported that lymph node metastases are Early postoperative recurrence and metastasis of ICC patients affect the most important independent risk factors for long-term survival. Therefore, patients who can be excised by preoperative assessment can be excised with radical resection, and patients with no evidence of lymph node metastasis may benefit from radical surgery. However, there is no lymph node metastasis in the current preoperative examination. The diagnosis has high accuracy and sensitivity, so in the process of radical operation of ICC, except for the resection of the tumor itself, the exploration and removal of lymph nodes in the related areas are becoming more and more important in the field of surgery. The lymph nodes containing tumor cells are not necessarily completely enlarged, so it seems unreliable to determine whether the lymph nodes are removed by biopsy or dissection according to the results of empirical exploration. More prudent, there is now a study that it can provide valuable information for prognostic judgement and disease staging, but the controversial point is whether positive conventional lymph node dissection can indeed improve patients' prognosis and benefit patients. So, for preoperative assessment of surgical excision (R0 excision), ICC patients should be routinely performed during the operation. Lymph node dissection is worthy of further study. To this end, a retrospective analysis of R0 excised ICC patients was conducted to observe the factors associated with the survival of the patients (including lymph node metastasis in the postoperative recurrence and survival of the patients), and to analyze the effect of lymph node dissection on the prognosis of the patients. Analysis of the influencing factors associated with lymph node metastasis, mainly to explore whether conventional lymph node dissection is of clinical significance. The research method is a retrospective collection of patients who were diagnosed as intrahepatic cholangiocarcinoma (ICC) in the Eastern Department of hepatobiliary surgery affiliated to Second Military Medical University from January 2010 to December 2015. (1) there was no clear evidence of lymph node metastasis before operation, the radical excision of the intrahepatic lesions (2) the pathological confirmation was ICC (3) the suspected lymph nodes were detected during the operation (3), then the lymph node dissection was carried out. (1) the non radical excision (palliative resection or postoperative pathologically positive patients) (2) only performed suspicious lymph node excision biopsy. (3) missing cases and missing persons. (4) the cause of death was not related to the disease itself. Finally, 265 cases (132 cases of intraoperative lymph node dissection) were included. Radical excision was defined as a complete resection of the intrahepatic tumor, and the postoperative pathology confirmed the negative margin of the intrahepatic tumor, and the lymph node dissection was performed in the intraoperative exploration of lymph nodes. Lymph node dissection. Definition of sweep scope: at least including the hepatic and duodenal ligaments around the hepatic artery, including the lymph nodes in the hepato duodenal ligament, including the hepatic and gastric ligaments, and the lymph nodes around the head of the pancreas. The preoperative clinical data (sex, age, hepatitis B, hepatitis C, biliary tract, diabetes, hypertension, AFP, preoperative CEA, preoperative CA-199, and preoperative CA-199) were collected. The preoperative TB value, preoperative ALT value, etc., intraoperative conditions (tumor size, tumor peripheral Subfocus, vascular invasion, portal blocking time, intraoperative bleeding amount, etc.) and postoperative pathological data (tumor qualitative, tumor differentiation, tumor margin status, lymph node pathological results) and postoperative follow-up data of patients. The main use of Cox single factor analysis method A single factor analysis of prognostic factors was carried out with P0.05 as the standard, statistical factors were included in multiple factor analysis, risk ratio (HR) was expressed as a risk or protective factor. Kaplan-Meier survival analysis and propensity paired analysis (PSM) were used to analyze the survival situation and draw related survival curves, and log-rank method was used to check the students. The survival rate and P0.05 were statistically significant. Using the chi square test to analyze the differences in postoperative complications, P0.05 was statistically significant. Logistic regression analysis was used to analyze the influence factors of lymph node metastasis, and the difference was statistically significant. The results of the study as of December 2015, were observed in 265 patients with recurrence and metastasis. A total of 196 cases (74%) were killed in 151 cases (57%) with a median follow-up of 33.5 months. The total 1,2,3 tumor free survival of all patients was 50%, 29%, 20%, and median survival time was 11.9 months; the total survival rate of 1,2,3 was 77%, 47%, 36%, and total median survival time was 22.8 months. The results of Cox multivariate analysis of prognostic factors showed that the patients had no tumor. The factors of survival were: diabetes mellitus (P=0.03, HR 1.626), high level of CA-199 (P=0.002, HR 1.001), tumor diameter more than 5cm (P=0.034, HR 1.410), peripheral tumor (P=0.012, HR 1.617), lymph node dissection (P=0.001; HR 0.451), and the factors affecting the survival of the patients. 9, HR 1.639, vascular invasion (P=0.007; HR 2.526), lymph node dissection (P=0.001; HR 0.396). (1) before PSM: 132 cases (79 cases of recurrent and metastatic patients, 59.8% in the group, 29.8% of the total, 52 cases of lymph node pathological diagnosis), 133 cases in the non dissection group (117 cases of relapse and metastasis, accounting for 87.9%, total 44.2%). (1) no tumor. Survival comparison: 1,2,3 year free survival rate: 65%, 41%, 30% in the scavenging group, 36%, 18%, 12%, (P=0.001), the median survival time: 18 months in the scavenging group, and 9 months in the non cleaning group; (2) the overall survival rate: the total survival rate of 1,2,3: the cleaning group 86%, 66%, 51%, 69%, 32%, and (P=0.001). Group 42 months, unscavenged group 17 months. (two) PSM after the cleaning group 77 cases, unscavenging group 77 cases. (1) no tumor survival comparison: 1,2,3 year free survival rate: scavenging group 68%, 47%, 36%, 31%, 13%, 6%, (P=0.001), median survival time: cleaning group 22.2 months, unscavenging group for two months; total survival comparison: 1,2,3 year total birth The survival rate: 91%, 75%, 56%, 71%, 30%, 21%, (P=0.001) in the dissection group. The median total survival time was 46.8 months in the cleaning group and 17 months in the non cleaning group. The lymph node positive patients in the dissection group were compared with the negative and non dissection patients in the cleaning group: (1) before PSM: 80 cases of negative lymph node negative group and 133 in the non dissection group. (1) non tumor survival: 1,2,3 years of tumor free survival: 76%, 56%, 44%, 36%, 18%, 12%, (P=0.001) in the group of uncleared lymph nodes, 36%, 18%, 12%, (P=0.001). The total survival rate of the dissection lymph node negative group was 27.9 months, and the undissection group was 9 months. (2) total survival rate of the group (2): the total survival rate of the lymph node negative group: cleaning lymph node negative group 95%, 78%, 65%, uncleared. Group 69%, 32%, 24%, (P=0.001). Median total survival time: 48 months of lymph node negative group and 17 months in non cleaning group. (3) postoperative complications were not statistically significant. (two) after PSM: 50 cases of lymph node negative group and 50 cases in non cleaning group. (1) no tumor survival rate: 1,2,3 year free survival rate: lymph node negative group 77%, 60 %, 52%, 32%, 22%, 15%, (P=0.001), median survival time: 38.1 months of lymph node negative group and 9 months in the non cleaning group; (2) total survival comparison: 1,2,3 year total survival rate: 94%, 82%, 74%, lymph node negative group, 94%, 40%, 28%, (P=0.001). Median total survival time: cleaning lymph node negative group for 22% months. 18.9 months in the non cleaning group. In the analysis of the factors affecting lymph node metastasis, the tumor diameter was more than 5cm (P=0.012, HR 1.859), and the preoperative CA-199 level (P=0.002, HR 2.415) was an independent risk factor affecting the lymph node metastasis. Conclusion 1. for R0 excised ICC patients, diabetes history, preoperative CA-199 high, tumor diameter more than 5cm, Tumor associated with subfoci is an independent risk factor for cancer free survival. Preoperative CA-199 high level, tumor diameter more than 5cm, vascular invasion is an independent risk factor affecting the total survival of the patient. Lymph node dissection in.2. surgery is a protective factor for the survival of ICC patients undergoing R0 resection. The results of.3. group comparison show that lymphadenectomy Cleaning can improve the prognosis of patients with the high level of CA-199 before.4., and the tumor diameter more than 5cm is an independent risk factor for lymph node metastasis in ICC patients. Intraoperative lymph node dissection can improve the prognosis of ICC patients, while obtaining lymph node pathology is helpful to the prognosis of patients and the formulation of postoperative adjuvant therapy strategy. The preoperative diagnosis is not clear. The evidence of lymph node metastasis is used to evaluate the ICC patients with radical resection, especially the high level of CA-199 before operation. The patients with larger diameter should take positive routine lymph node dissection during the operation.

【學(xué)位授予單位】：第二軍醫(yī)大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R735.8

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