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ESGE2022指南更新:胃肠道浅表病变的ESD

Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2022

浅表性胃肠道病变的内镜膜下剥离术:欧洲胃肠内镜学会ESGE指南–2022年更新

阅读提示

Criteria for curativeness of resection should guide management:

切除治愈性标准应为管理提供指导:

A. Curative/very low risk resection (LNM risk < 0.5 %–1 %): En bloc R0 resection; dysplastic/pT1a, differentiated lesion, no lymphovascular invasion, independent of size if no ulceration and ≤ 3 cm if ulcerated.

治愈性/极低风险切除(LNM风险<0.5%–1%):整块R0切除;异型增生/pT1a,分化病变,无淋巴血管浸润,无溃疡时任意病变尺寸,存在溃疡的话,病变尺寸≤3cm。

B.Curative/low risk resection (LNM risk < 3 %): En bloc R0 resection; lesion with no lymphovascular invasion and:

pT1a, predominant type is poorly differentiated or undifferentiated, size ≤ 2 cm, no ulceration; and

pT1b, invasion ≤ 500 µm, differentiated, size ≤ 3 cm.

治愈性/低风险切除(LNM风险<3%):整块R0切除;无淋巴血管浸润的病变以及:

pT1a,主要分型为低分化或未分化,尺寸≤2cm,无溃疡;

pT1b,浸润深度≤500 µm,分化型,尺寸≤3cm。

C.Local-risk resection (very low risk of LNM but increased risk of persistence/recurrence):

Piecemeal resection or tumor-positive horizontal margin of a lesion otherwise meeting curative/very low risk criteria;

Provided that there is no submucosally invasive tumor at the resection margin: piecemeal resection or tumor-positive horizontal margin; pT1b; invasion ≤ 500 µm; well-differentiated; size ≤ 3 cm; VM0.

局部风险切除(LNM风险非常低,但持续/复发风险增加):

病灶的分块切除或肿瘤水平边缘阳性,否则符合治愈/极低风险标准;

前提是切缘无黏膜下浸润性肿瘤:分块切除或肿瘤水平切缘阳性;pT1b;浸润深度≤500µm;分化良好;尺寸≤3 cm;VM0。

D. High risk resection (noncurative): Any lesion with any of the following:

positive vertical margin;

lymphovascular invasion;

deep submucosal invasion (> 500 µm from the muscularis mucosae);

ulceration or size > 2 cm, in poorly differentiated lesions;

size > 3 cm in pT1b differentiated lesions with submucosal invasion < 500 µm, or in intramucosal ulcerative lesions.

高风险切除(非治愈性):具有以下任何一种的任何病变:

垂直切缘阳性;

淋巴血管浸润;

深层黏膜下浸润(从黏膜肌层开始> 500 µm);

溃疡或病灶尺寸> 2 cm,分化差的病灶;

尺寸>3cm的pT1b分化病变,黏膜下浸润深度<500 µm,或黏膜内溃疡性病变。

SOURCE AND SCOPE

来源和范围

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It is an update of the previous 2015 Guideline addressing the role of endoscopic submucosal dissection (ESD) for superficial gastrointestinal lesions.

本指南是欧洲胃肠道内镜学会(ESGE)的官方声明。它是先前发布的2015年指南的修订版,阐述了内镜黏膜下剥离术(ESD)在浅表性胃肠道病变中的作用。

Pretreatment evaluation

治疗前评估

1 ESGE recommends that the evaluation of superficial gastrointestinal lesions should be done by an experienced endoscopist, using high definition white-light and chromoendoscopy (virtual or dye-based), and validated classifications when available.

ESGE建议:应由经验丰富的内镜医师使用高分辨率白光内镜和染色内镜(虚拟染色内镜或色素染色内镜)以及经验证的分类方法(如可用)评估浅表性胃肠道病变。

Strong recommendation, high quality evidence.

强推荐,证据质量较高。

2 ESGE does not recommend routine performance of endoscopic ultrasonography (EUS), computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography CT (PET-CT) prior to endoscopic resection (ER).

ESGE不建议在内镜下切除术(ER)前常规进行内镜超声检查(EUS)、计算机断层扫描(CT)、磁共振成像(MRI)或正电子发射断层扫描(PET-CT)。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

3 ESGE suggests that when suspicious features for deep submucosal invasion are present, complete staging should be considered in order to exclude stage T2/T3 or lymph node metastasis (LNM).

ESGE建议:当存在黏膜下深层浸润性病变的可疑特征时,为了排除T2/T3期病变或淋巴结转移(LNM),应考虑进行全面分期手术。

Weak recommendation, low quality evidence.

弱推荐,证据质量较低。

Therapeutic options

治疗选择

4 ESGE recommends ESD as the treatment of choice for most esophageal squamous cell and gastric (or junctional non-Barrett’s) superficial lesions, mainly to provide an en bloc potentially curative resection with accurate pathologic staging.

ESGE建议:将内镜黏膜下剥离术(ESD)作为大多数食管鳞癌和胃(或食管胃结合部非Barrett食管)浅表病变的首选治疗方法,主要是在准确的病理分期下进行具有潜在治愈性的整块切除。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

5 ESGE suggests that ESD might also be considered for en bloc resection of noncircumferential clinically staged T1a-m3/T1b-sm1 or for circumferential clinically staged T1a-m1/m2 esophageal squamous cell carcinoma (SCC).

ESGE建议:对于非环周切缘临床分期为T1a-m3/T1b-sm1病变,可考虑采用ESD进行整块切除,对于环周切缘临床分期为T1a-m1/m2的食管鳞癌(SCC),也可考虑进行ESD。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

6 For BE-associated lesions, ESGE recommends to use EMR for ≤ 20mm visible lesions with low probability of submucosal invasion (Paris type 0-IIa, 0-IIb) and for larger or multifocal benign (dysplastic) lesions.

ESGE建议:对于BE相关病变,应对≤20mm的可见病变、黏膜下浸润可能性较低(巴黎0-IIa型、0-IIb型),以及尺寸更大或多灶性良性(异型增生)病变进行EMR。

Strong recommendation, high quality evidence.

强推荐,证据质量较高。

7 For BE-associated lesions, ESGE suggests to use ESD for lesions suspicious for submucosal invasion (Paris type 0-Is, 0-IIc), for malignant lesions > 20mm, and for lesions in scarred/fibrotic areas.

ESGE建议:对于BE相关病变,应对疑似黏膜下浸润的病变(巴黎0-Is型,0-IIc型)、>20mm的恶性病变以及位于瘢痕/纤维化区域的病变进行ESD。

Weak recommendation, low quality evidence.

弱推荐,证据质量较低。

8 ESGE recommends ESD for differentiated gastric lesions clinically staged as dysplastic or as intramucosal carcinomas (of any size if not ulcerated and ≤ 30mm if ulcerated), with EMR being an alternative for Paris 0-IIa lesions of size ≤ 10 mm with low likelihood of malignancy.

ESGE建议:对临床分期为异型增生或黏膜内癌的分化型胃部病变进行ESD(如果无溃疡,则任意大小的病变;如果存在溃疡,则直径≤30mm的病变),而EMR可作为巴黎0-IIa型病变(尺寸≤10mm,恶性肿瘤可能性较低)的另一种选择。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

9 ESGE suggests that gastric adenocarcinomas that are ≤ 30mm, submucosal (sm1), and well-differentiated, or ≤ 20 mm, intramucosal, and poorly differentiated type, both without ulcerative findings, can be considered for ESD, although the decision should be individualized.

ESGE建议:对于≤30mm、黏膜下层浅层浸润(sm1)高分化型胃腺癌,或≤20mm的黏膜内低分化型胃腺癌,如果均无溃疡表现,则可考虑进行ESD,虽然应根据具体情况而定。

Weak recommendation, low quality evidence.

弱推荐,证据质量较低。

10 ESGE does not recommend routine use of ESD for duodenal or small-bowel lesions, with its use being reserved for selected cases in expert centers.

ESGE不建议对十二指肠病变或小肠病变常规进行ESD,ESD的使用应仅限于专家中心的特定病例。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

11 ESGE recommends polypectomy and/or EMR (en bloc or piecemeal) as the treatment of choice for most duodenal and small-bowel superficial lesions.

ESGE建议:将息肉切除术和/或EMR(整块切除或分块切除)作为大多数十二指肠浅表病变和小肠浅表病变的首选治疗。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

12 ESGE recommends polypectomy and/or EMR (en bloc or piecemeal) as the treatment of choice for most superficial colorectal lesions.

ESGE建议:将息肉切除术和/或EMR(整块切除或分块切除)作为大多数结直肠浅表性病变的首选治疗。

Strong recommendation, high quality evidence.

强推荐,证据质量较高。

13 ESGE suggests that ESD should be considered for en bloc resection of colorectal (but particularly rectal) lesions with suspicion of limited submucosal invasion (demarcated depressed area with irregular surface pattern or a large protruding or bulky component, particularly if the lesions are larger than 20mm), or for lesions that otherwise cannot be completely removed by snare-based techniques.

ESGE建议:对于怀疑黏膜下浸润深度有限的结直肠(但特别是直肠)病变(凹陷区域边界清晰、表面结构不规则或大的腔内突出型或肿块体积较大的结直肠肿瘤,尤其是在病变直径大于20mm的情况下),可考虑采用ESD进行整块切除,对于使用圈套器技术不能完全切除的病变,也可考虑进行ESD。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

Management after endoscopic resection

内镜下切除术后的管理

Esophageal SCCs

食管鳞状细胞癌(SCC)

14 ESGE recommends that an en bloc R0 resection of a superficial esophageal squamous cell lesion with histology no more advanced than intramucosal m2 cancer, well to moderately differentiated, with no lymphovascular invasion, should be considered a very low risk (curative) resection and no further staging procedure or treatment is recommended.

ESGE建议:对于组织学上浸润深度不高于m2(浸润至黏膜层中层)、中高度分化、无淋巴血管浸润的浅表性食管鳞状细胞癌,整块R0切除手术风险极低(为治愈性切除),不建议进行进一步分期手术或治疗。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据

15 ESGE suggests that an en bloc R0 resection of an esophageal m3 or sm1 SCC that is well to moderately differentiated and with no lymphovascular invasion, should be considered a low risk (curative) resection and no further treatment is generally recommended.

ESGE建议:对中高度分化且无淋巴血管浸润的食管m3(浸润至黏膜肌层)或sm1(浸润至黏膜下层上1/3) SCC,整块R0切除手术风险较低(为治愈性切除),通常不建议进行进一步治疗。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

However, in these cases, particularly if the lesion is bigger than 20mm, there is a real (albeit low) risk of LNM and complete staging is recommended, with the risk from further therapy being balanced against the risk of LNM, in a multidisciplinary discussion.

然而,在这些情况下,特别是病变直径大于20mm时,存在淋巴结转移(LNM)(尽管较低)的风险,且建议进行全面分期手术,并在多学科讨论中,应权衡进一步治疗与LNM的风险,从而决定是否进行进一步治疗。

Weak recommendation, low quality evidence.

弱推荐,证据质量较低。

16 ESGE suggests that complementary radiotherapy or CRT may be considered in a multidisciplinary discussion after a curative resection of esophageal m3/sm1 SCC (particularly if > 20 mm in size).

ESGE建议:在食管m3/sm1 SCC(尤其是直径>20 mm时)根治性切除术后,在多学科讨论中可考虑补充放疗或适形放疗(CRT)。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

BE-associated lesions

BE相关病变

17 ESGE recommends that an en bloc R0 resection of a BE-associated superficial lesion with histology no more advanced than intramucosal cancer, well to moderately differentiated, with no lymphovascular invasion, should be considered a very low risk (curative) resection and no further staging procedure is generally recommended.

ESGE建议:对于组织学上局限于黏膜内、中高度分化、无淋巴血管浸润的BE相关浅表病变,整块R0切除手术风险极低(为治愈性切除),且通常不建议进行进一步分期手术。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

18 ESGE suggests that an en bloc R0 resection of a BE-associated superficial lesion with superficial submucosal invasion (sm1), and that is well to moderately differentiated, and with no lymphovascular invasion, should be considered a low risk (curative) resection and no further treatment (except for ablation of BE tissue) is generally recommended.

ESGE建议:对于浸润至黏膜下层浅层(sm1)、中高度分化,无淋巴血管浸润的BE相关浅表病变,整块R0切除是一种低风险(治愈性)的切除方法,且通常不建议进行进一步治疗(BE组织消融术除外)。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

However, in these cases, there is a real (albeit low) risk of LNM, and complete staging is recommended with the risk from further therapy (surgery) being balanced against the risk of LNM, in a multidisciplinary discussion.

然而,在这些情况下,却真实存在LNM的风险(尽管较低),并建议进行全面分期手术,且在多学科讨论中,权衡考虑进一步治疗(外科手术)的风险与LNM的风险,从而决定是否进行进一步治疗。

Weak recommendation, low quality evidence.

弱推荐,低质量证据。

19 ESGE recommends ablation of all of the Barrett’s mucosa after a curative or local-risk resection.

ESGE建议:在进行治愈性切除或局部风险切除(local-risk resection)后,对所有的Barrett食管黏膜进行消融。

Strong recommendation, high quality evidence.

强推荐,证据质量较高。

Gastric lesions

胃部病变

20 ESGE recommends that an en bloc R0 resection of a superficial gastric lesion with histology no more advanced than intramucosal cancer, well to moderately differentiated, with no lymphovascular invasion, should be considered a very low risk (curative) resection, independently of size if without ulceration or of lesions ≤ 30mm if ulcerated; and no further staging procedure or treatment is generally recommended.

ESGE建议:对于组织学上浸润深度局限于黏膜内、中高度分化、无淋巴血管浸润的胃浅表病变(如果无溃疡,则病变可为任意大小,如果存在溃疡,则病变直径应≤30 mm),整块R0切除风险极低(为治愈性切除),且通常不建议进行进一步分期手术或治疗。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

21 ESGE suggests that an en bloc R0 resection of a ≤ 30mm gastric adenocarcinoma, with superficial submucosal invasion (sm1), that is well to moderately differentiated and with no lymphovascular invasion and no ulcer, should be considered a low risk (curative) resection, and no further treatment is generally recommended.

ESGE建议:对于≤30mm、浸润至黏膜下层浅层(sm1),中高度分化,无淋巴血管浸润且无溃疡的胃腺癌,整块切除/R0切除风险较低(为治愈性切除),且通常不建议进行进一步治疗。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

However, in these cases there is a real (albeit low) risk of LNM and complete staging is recommended with the risk from further therapy (surgery) being balanced against the risk of LNM, in a multidisciplinary discussion.

然而,在这些情况下,存在LNM的真实(尽管较低)风险,并建议进行全面分期手术,且在多学科讨论中,应权衡考虑进一步治疗(外科手术)与LNM的风险,从而决定是否进行进一步治疗。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

22 ESGE suggests that an en bloc R0 resection of a ≤ 20mm gastric intramucosal poorly differentiated carcinoma, with no lymphovascular invasion or ulcer, should be considered a low risk (curative) resection and no further treatment is generally recommended.

ESGE建议:对于≤20mm、无淋巴血管浸润或溃疡的低分化胃黏膜内癌,整块切除/R0切除风险较低(为治愈性切除),且通常不建议进行进一步治疗。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

However, in these cases there is a real (albeit low) risk of LNM and complete staging is recommended with the risk from further therapy (surgery) being balanced against the risk of LNM, in a multidisciplinary discussion.

然而,在这些情况下,存在LNM的真实(尽管较低)风险,并建议进行全面分期手术,且在多学科讨论中,应权衡考虑进一步治疗(外科手术)的风险与LNM的风险,从而决定是否进行进一步治疗。

Weak recommendation, moderate quality evidence.

弱推荐,中等质量证据。

23 ESGE recommends that a resection of a > 30mm gastric adenocarcinoma with superficial submucosal invasion (sm1) or with ulceration should be considered a high risk (noncurative) resection, and complete staging should be done and strong consideration for additional treatments (surgery) should be given, on an individual basis in a multidisciplinary discussion.

ESGE建议:对于>30mm、浸润至黏膜下层浅层(sm1)或存在溃疡的胃腺癌,切除的手术风险较高,且为非治愈性切除,应进行全面分期手术,并在多学科讨论中,根据个体情况强烈考虑进行其他的治疗(外科手术)。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

Duodenal and small-bowel lesions 

十二指肠病变和小肠病变

24 ESGE suggests that, given the lack of evidence, the same post-resection criteria as in the colon should apply to the management of duodenal and small-bowel lesions, on an individual basis and with a multidisciplinary approach.

ESGE建议:因为目前缺乏相关证据,对于十二指肠病变和小肠病变,切除术后的标准与结肠一致,并依据个体情况,采用多学科的方法进行管理。

Weak recommendation, very low quality evidence.

弱推荐,证据质量极低。

Colorectal lesions

结直肠病变

25 ESGE recommends that an en bloc R0 resection of a colorectal lesion with histology no more advanced than intramucosal adenocarcinoma, well to moderately differentiated with no lymphovascular invasion, should be considered a very low risk (curative) resection and no further staging procedure or treatment is generally recommended.

ESGE建议:对于组织学上浸润深度局限于黏膜内、中高度分化、无淋巴血管浸润的结直肠腺癌,整块R0切除手术风险极低(为治愈性切除),且通常不建议进行进一步分期手术或治疗。

Strong recommendation, high quality evidence.

强推荐,证据质量较高。

26 ESGE recommends that an en bloc R0 resection of a colorectal lesion with superficial submucosal invasion (sm1), that is well to moderately differentiated and with no lymphovascular invasion and no grade 2 or 3 budding, should be considered a low risk (curative) resection, and no further treatment is generally recommended.

ESGE建议:对于浸润至黏膜下层浅层(sm1)、中高度分化且无淋巴血管浸润、无2级或3级出芽的结直肠病变,整块R0切除风险较低(为治愈性切除),通常不建议进行进一步治疗。

Strong recommendation, high quality evidence.

强推荐,证据质量较高。

27 ESGE suggests that after an en bloc R0 resection of a rectal lesion meeting the single high risk criterion of submucosal invasion deeper than sm1 (well to moderately differentiated with no lymphovascular invasion and no grade 2 or 3 budding), CRT and/or surveillance might be preferred over surgery on an individual basis in a multidisciplinary approach.

ESGE建议:对于满足浸润深度超过sm1的单一高风险标准的直肠病变(中高度分化,无淋巴血管浸润,无2级或3级出芽),整块R0切除后,在多学科方法中,基于个体情况,CRT和/或监测可能会优于外科手术。

Weak recommendation, very low quality evidence.

弱推荐,证据质量极低。

All organs

所有器官

28 ESGE recommends that after an endoscopic complete resection, if there is a positive horizontal margin or if resection is piecemeal but there is no submucosal invasion and no other high risk criteria are met, this should be considered a local-risk resection and endoscopic surveillance/re-treatment is recommended rather than surgery or other additional treatment.

ESGE建议:在内镜下完全切除后,如果水平切缘阳性或为分块切除,但无黏膜下浸润且不符合其他高风险标准,应将切除视为局部风险切除(local-risk resection),建议进行内镜监测/再治疗,而不是外科手术或其他的额外治疗。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

29 ESGE recommends that when there is a diagnosis of lymphovascular invasion or deeper infiltration than sm1 or positive vertical margins or undifferentiated tumor or, for colorectal lesions, grade 2 or 3 budding, that the resection should be considered a high risk (noncurative) resection; complete staging should be done and strong consideration for additional treatments (chemoradiotherapy and/or surgery) should be given, on an individual basis in a multidisciplinary discussion.

ESGE建议:当诊断为淋巴血管浸润,或浸润深度超过sm1,或垂直边缘阳性,或未分化肿瘤,或对于结直肠病变,存在2级或3级出芽时,应将切除视为高风险性(非治愈性)切除,应进行全面分期手术,并在多学科讨论中,根据个体情况,强烈考虑进行额外的治疗(放化疗和/或外科手术)。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

Surveillance after endoscopic resection

内镜切除术后的监测

30 ESGE recommends scheduled endoscopic surveillance with high definition white-light and chromoendoscopy (virtual or dye-based) with biopsies of only the suspicious areas after a curative ESD.

ESGE建议:使用高分辨率白光内镜和染色内镜(虚拟染色内镜或色素染色内镜)按计划进行内镜监测,在治愈性ESD后仅对可疑区域进行活检。

Strong recommendation, moderate quality evidence.

强推荐,中等质量证据。

31 ESGE recommends that after piecemeal resection or in the presence of positive lateral margins when criteria for additional treatment are not met, a high definition chromoendoscopy (virtual and/or dye-based) with biopsies is recommended at 3–6 months.

ESGE建议:在分块切除后或存在切缘阳性的情况下,当不符合进行额外治疗的标准时,建议在3-6个月时,采用高分辨率染色内镜(虚拟染色内镜和/或色素染色内镜)进行检查和活检。

Weak recommendation, low quality evidence.

弱推荐,证据质量较低。

32 For upper GI superficial lesions, ESGE suggests endoscopy at 3–6 months and then annually after a curative ESD resection or after a local-risk ESD resection without recurrence.

ESGE建议:对于上消化道浅表病变,在治愈性ESD切除后,或局部风险性ESD切除后无复发的情况下,应在3-6个月时进行内镜检查,随后每年进行一次内镜检查。

Weak recommendation, low quality evidence.

弱推荐,证据质量较低。

33 ESGE suggests colonoscopy at 12 months and then further surveillance in accordance with polypectomy and colorectal cancer guidelines, after a local-risk ESD resection without recurrence or after a low or very low risk (curative) ESD of a colorectal malignant lesion.

ESGE建议:在局部风险性ESD切除术后无复发的情况下,或在结直肠恶性病变低-极低风险性(治愈性)ESD后,在12个月时进行结肠镜检查,然后依据息肉切除术和结直肠癌指南进行进一步监测。

Weak recommendation, low quality evidence.

弱推荐,证据质量较低。

34 ESGE does not suggest routine use of EUS, MRI, CT, or PET in the follow-up after a very low or low risk (curative) endoscopic resection, but this might be considered in the cases of T1a-m3 /T1b-sm1 esophageal SCC particularly if no additional treatment has been decided.

ESGE不建议在低-极低风险(治愈性)内镜切除术后的随访中常规使用EUS、MRI、CT或PET,但对于T1a-m3/T1b-sm1食管SCC,则可考虑使用这些方法,尤其是在未决定是否进行额外治疗的情况下。

Weak recommendation, very low quality evidence.

弱推荐,证据质量极低。

ESGE2022指南更新:胃肠道浅表病变的ESD(英文全文)

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