多中心Ⅱ期经肛门全直肠系膜切除术治疗直肠癌的临床研究：初步结果。

Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.

机构信息

Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY, USA.

Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL, USA.

出版信息

Surg Endosc. 2023 Dec;37(12):9483-9508. doi: 10.1007/s00464-023-10266-9. Epub 2023 Sep 12.

BACKGROUND

Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765).

METHODS

100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications.

RESULTS

Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003).

CONCLUSION

When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.

背景

经肛门全直肠系膜切除术（taTME）结合腹部和经肛门解剖，以促进低位直肠肿瘤患者的肛门括约肌保留。很少有 II/III 期试验报告长期的肿瘤学和功能结果。我们报告了一项北美前瞻性多中心 II 期 taTME 试验（NCT03144765）的早期结果。

方法

11 个中心共纳入 100 例位于距肛缘（AV）≤10cm 的 I-III 期直肠腺癌患者。主要和次要终点是 TME 质量、病理结果、30 天和 90 天结果以及造口关闭率。采用单变量回归分析评估不完全 TME 和吻合口并发症的危险因素。

结果

2017 年 9 月至 2022 年 4 月，70 名男性和 30 名女性接受了 2 队 taTME 治疗，中位年龄为 58 岁（四分位距 49-62），BMI 为 27.8kg/m（四分位距 23.9-31.8kg/m），肿瘤位于距 AV 中位 5.8cm（四分位距 4.5-7.0cm）处。69%的患者完成了新辅助放疗。行内括约肌切除术的患者占 36%，所有患者均行转流术。术中并发症发生率为 8%，包括 3 例器官损伤、2 例腹部和 1 例经肛门中转。30 天和 90 天的发病率分别为 49%（Clavien-Dindo（CD）≥3 为 28.6%）和 56%（CD≥3 为 30.4%，包括 1 例死亡）。吻合口并发症的发生率为 18%，其中 10%在 30 天内诊断。男性吻合口风险较高（p=0.05）。在中位随访 5（四分位距 3.1-7.4）个月时，98%的造口已关闭。TME 分级为完全或接近完全，占 90%，2 例（3%）有阳性切缘。不完全 TME 的危险因素包括 ASA≥3（p=0.01）、新辅助放疗与手术之间时间延长（p=0.03）和手术出血量增加（p=0.003）。