【背景与目的】

EMR-Cap是早期食管癌和癌前病变的较为传统的内镜下切除技术（ER），这项技术每次切除前需要黏膜下注射且每切除一块病变需要一根圈套丝，而MBM运用了经改装的曲张静脉结扎器，不需要内镜下注射，使内镜下多块黏膜切除变得相对简单、快捷。国内外尚无两种技术的随机对照研究，本课题主要随机对比EMR-Cap与MBM在治疗早期食管癌和癌前病变的异同。

射频消融术（RFA）在Barrett食管治疗已经成熟，国内仅有我院报道，但样本量小，本课题将扩大病例数进一步评估其在治疗表浅平坦型早期食管癌（0-IIb型）和癌前病变的安全性及有效性。

【病例与方法】

1、EMR-Cap Vs MBM随机对照研究：选取活检病理为HGIN/ESCC、病变长度≥2cm≤6 cm、累及食管周围小于 2/3周病例，随机分配到EMR-Cap组和MBM组，主要观察指标：治疗时间，治疗费用，病变完全切除率，并发症，3月和12月随访时HGIN/ESCC 完全缓解率；

2、射频消融术（RFA）：选取需活检病理为MGIN、HGIN或0-IIb型表浅平坦型早期食管癌，病变长度≥3cm≤12cm，既往无内镜下切除或电凝治疗病史，应用HALO系统行内镜下消融治疗，每3个月复查，于治疗区域活检，如发现USL，活检后行HALO90局灶消融治疗，观察治疗后1年病变组织学上完全缓解率（CR）及并发症情况。

3、RFA联合ER技术：选取活检病理为HGIN、伴非表浅平坦型早期食管癌，病变长度≥3cm≤12cm，先行内镜下全周消融治疗，然后应用内镜下切除技术切除0-IIa/IIc型病变，观察3月和12月随访完全缓解率、并发症。

【结果】

1、EMR-Cap Vs MBM随机对照研究：共入组84例患者，男性59例，平均年龄60岁，EMR-Cap组和MBM组各42例，两组病例基本资料无明显差异，所有病变均一次性完整切除。MBM组切除平均时间明显短于EMR-Cap组（11vs.22 min，p<0.0001）。EMR-Cap组有1例穿孔，经保守治疗痊愈。MBM组治疗费用低于EMR-Cap组。3月和12月随访切除病变部位均无HGIN/ESCC残留及复发。

2、 RFA研究：共入组96例患者，其中MGIN 45例, HGIN 42例, 0-IIb早期ESCC 9例，3月和12月随访时CR分别为74% (70 /94) 和 87% (81/93)，2例（2%）患者疾病进展（1例由MGIN进展为HGIN，1例由HGIN进展为T1m2 ESCC），经内镜下治疗完全缓解。20例（21%）患者行HALO360全周消融治疗后出现狭窄。L+RFA 12 J/cm2 （单次消融，不清除）是最佳治疗技术方案（12月CR为82%，狭窄率为6%）。

3、RFA联合ER技术：共入组4例患者，均为男性，平均年龄62岁，ESCC 2例、MGIN 1例、HGIN1例，病变平均长度8.5cm，均顺利完成RFA+ER治疗，总治疗时间42-105（平均66.8），其中RFA时间为3~12（平均8.25）min，ER时间6~20（平均10.25）min，平均住院时间3d。4例术后均出现狭窄，其中2例为轻度狭窄，未予处理；2例为重度狭窄，行内镜下水囊扩张术均缓解。3例3个月及1年以上随访达到完全缓解，1例3个月复查发现HGIN，分别行HALO360和HALO90治疗后达到完全缓解。

【结论】

在保证相同治疗效果的情况下，与EMR-cap相比，MBM具有操作简单、缩短治疗时间、成本低的优点，适宜广泛推广和开展。RFA在治疗0-IIb表浅平坦型早期食管癌和癌前病变是安全的、有效的。在治疗范围广泛的非表浅平坦型早期食管癌和癌前病变时，与单纯应用ER技术相比，RFA联合ER降低了对操作者技术水平的要求，降低狭窄发生率，扩大了内镜下微创治疗的适应证。

【Background and Purpose】 Piecemeal endoscopic resection (ER) for esophageal high-grade intraepithelial neoplasia (HGIN) or early squamous cell carcinoma (ESCC) is usually performed with the ER-cap technique. This requires submucosal lifting and multiple snares. Multiband mucosectomy (MBM) uses a modified variceal-band ligator without submucosal lifting. MBM might be a better applicable ER-technique. The aim is to compare MBM to ER-cap for piecemeal ER of esophageal ESCC. Endoscopic radiofrequency ablation (RFA) is an established therapy for Barrett’s esophagus. Preliminary reports, limited by low patient numbers, suggest a possible role for RFA for early esophageal squamous cell neoplasia (ESCN), as well. The aim is to enlarge the patient numbers to value its efficiency and safety. 【Patients and Methods】 1. MBM vs EMR-Cap study:　Patients with mucosal HGIN/ESCC (≥2≤6 cm, max 2/3 of circumference) were included. Lesions were delineated after 1.25% Lugol staining, followed by randomisation to MBM or ER-cap and piecemeal resection. Endpoints: procedure-time, procedure-costs, complete endoscopic resection, adverse events, absence of HGIN/ESCC at 3 and 12 months follow-up. 2. RFA：All patients had ≥1 flat (type 0-IIb) unstained lesion (USL) on Lugol’s chromoendoscopy and consensus diagnosis of MGIN, HGIN, or early ESCC. Exclusions: prior endoscopic resection or ablation, stricture, non-flat mucosa. RFA was used at baseline to treat all USLs, then biopsy (and focal RFA if USL(s) persisted) every 3 months until all biopsies were negative for MGIN, HGIN and ESCC. Main outcome measurements: Complete response (CR) at 3 and 12 months (absence of MGIN, HGIN, and ESCC), neoplastic progression, adverse events. 3. RFA combined with ER:　Patients with early non-flat type ESCC and precancerous lesions (≥3cm≤12cm). RFA is used, then non-flat lesion is resected with MBM. To observe the proportion of patients with histological complete response (CR) at 3months, 12 months to 5 years and adverse events. 【Results】 1. MBM vs. EMR-Cap study:　In 84 patients (59 male, mean age 60 yrs) ER was performed with MBM (n=42) or ER-cap (n=42). There was no difference in baseline characteristics. Endoscopic complete resection was achieved in all lesions. Procedure time was significantly shorter with MBM (11 vs. 22 minutes, p<0.0001). One perforation was seen after ER-cap and treated conservatively. Total costs of disposables was less for MBM (p=0.04).At 3 and 12 months follow-up none of the patients demonstrated HGIN/ESCC at the resection site. 2. RFA study: 96 patients participated (MGIN 45, HGIN 42, early ESCC 9). At 3 and 12 months, respectively, 74% (70/94) and 87% (81/93) were CR. Two patients (2%) progressed (MGIN to HGIN; HGIN to T1m2 ESCC); both were treated endoscopically and achieved CR. Stricture occurred in 20 patients (21%), all after circumferential RFA. Lugol’s + RFA 12 J/cm2 (single application, no cleaning) was the optimal baseline circumferential technique (82% 12-month CR, 6% stricture). 3. RFA combined with ER study: In 4 patients, totally male, mean age 62 years with ESSCC (2), HGIN (1), MGIN (1) participated. USL length was 6-12（mean 8.5）cm. Total treatment time is 42-105（mean 66.8）min，RFA time 3-12 (mean 8.25) min, ER time 6-20(10.25) min. Average hospitalization day was 3days. There were 2 cases with sever strictures, all dilated to resolution. 3 cases were CR at 3-months, 1year till to 5 year. 1 case was found HGIN at 3month and MGIN at 1year and 3year follow up, CR after treated with HALO system. 【Conclusions】 Piecemeal ER of esophageal ESCC with MBM is faster and cheaper compared to EMR-cap. Both techniques are highly effective and safe. MBM may have significant advantages over the ER-cap technique, especially in countries where ESCC is extremely common but endoscopic expertise and resources are limited. In patients with early ESCN, RFA is associated with a high CR rate and acceptable safety profile. RFA combined with ER is effective, safe and less technique demanded in treating with patients diagnosed as early non-flat esophageal squamous cell carcinoma and precancerous lesions, thus enlarged the indications of endoscopic treatment.