Prospective Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Dec 27, 2022; 14(12): 1375-1386
Published online Dec 27, 2022. doi: 10.4240/wjgs.v14.i12.1375
Real-time in vivo distal margin selection using confocal laser endomicroscopy in transanal total mesorectal excision for rectal cancer
Jie Tan, Hong-Li Ji, Yao-Wen Hu, Zhi-Ming Li, Bao-Xiong Zhuang, Hai-Jun Deng, Ya-Nan Wang, Ji-Xiang Zheng, Wei Jiang, Jun Yan
Jie Tan, Hong-Li Ji, Yao-Wen Hu, Zhi-Ming Li, Bao-Xiong Zhuang, Hai-Jun Deng, Ya-Nan Wang, Ji-Xiang Zheng, Wei Jiang, Jun Yan, Department of General Surgery, Nanfang Hospital, Guangzhou 510515, Guangdong Province, China
Jun Yan, Department of General Surgery, Southern Medical University, Guangzhou 510515, Guangdong Province, China
Jun Yan, Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Tumor, Nanfang Hospital, Guangzhou 510515, Guangdong Province, China
Author contributions: J Yan and Tan J designed the research study; Tan J, Ji HL, Hu YW, Li ZM, Zhuang BX, Deng HJ, Wang YN, Zheng JX, Wang T, Jiang W, Han ZL, and Yan J performed the research; Tan J, Ji HL, Hu YW, Li ZM, Zhuang BX, Deng HJ, Wang YN, Zheng JX, Wang T, Jiang W, Han ZL, and Yan J analyzed the data and wrote the manuscript; and all authors have read and approve the final manuscript.
Supported by the National Natural Science Foundation of China, No. 82273360; the Science and Technology Planning Project of Guangzhou City, No. 202206010085; the Clinical Research Project of Southern Medical University, No. LC2016PY010; and the Clinical Research Project of Nanfang Hospital, No. 2018CR034.
Institutional review board statement: The study was reviewed and approved by the Southern Medical University Nanfang Hospital Institutional Review Board (Approval No. NFEC-2017-091).
Clinical trial registration statement: This study is registered at Clinical Trial. The registration identification number is NCT04016948.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at yanjunfudan@163.com.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jun Yan, MD, PhD, Chief Doctor, Professor, Surgeon, Department of General Surgery, Nanfang Hospital, No. 1838 North Guangzhou Road, Guangzhou 510515, Guangdong Province, China. yanjunfudan@163.com
Received: July 16, 2022
Peer-review started: July 16, 2022
First decision: October 30, 2022
Revised: November 13, 2022
Accepted: December 6, 2022
Article in press: December 6, 2022
Published online: December 27, 2022
Processing time: 164 Days and 1.4 Hours
Abstract
BACKGROUND

Transanal total mesorectal excision (TaTME) allows patients with ultralow rectal cancer to be treated with sphincter-saving surgery. However, accurate delineation of the distal resection margin (DRM), which is essential to achieve R0 resection for low rectal cancer in TaTME, is technically demanding.

AIM

To assess the feasibility of optical biopsy using probe-based confocal laser endomicroscopy (pCLE) to select the DRM during TaTME for low rectal cancer.

METHODS

A total of 43 consecutive patients who were diagnosed with low rectal cancer and scheduled for TaTME were prospectively enrolled from January 2019 to January 2021. pCLE was used to determine the distal edge of the tumor as well as the DRM during surgery. The final pathological report was used as the gold standard. The diagnostic accuracy of pCLE examination was calculated.

RESULTS

A total of 86 pCLE videos of 43 patients were included in the analyses. The sensitivity, specificity and accuracy of real-time pCLE examination were 90.00% [95% confidence interval (CI): 76.34%-97.21%], 86.96% (95%CI: 73.74%-95.06%) and 88.37% (95%CI: 79.65%-94.28%), respectively. The accuracy of blinded pCLE reinterpretation was 86.05% (95%CI: 76.89%-92.58%). Furthermore, our results show satisfactory interobserver agreement (κ = 0.767, standard error = 0.069) for the detection of cancer tissue by pCLE. There were no positive DRMs (≤ 1 mm) in this study. The median DRM was 7 mm [interquartile range (IQR) = 5-10 mm]. The median Wexner score was 5 (IQR = 3-6) at 6 mo after stoma closure.

CONCLUSION

Real-time in vivo pCLE examination is feasible and safe for selecting the DRM during TaTME for low rectal cancer (clinical trial registration number: NCT04016948).

Keywords: Transanal total mesorectal excision; Probe-based confocal laser endomicroscopy; Optical biopsy; Distal resection margin; Low rectal cancer

Core Tip: Transanal total mesorectal excision (TaTME) allows patients even with ultra-low rectal cancer to be treated with sphincter-saving surgery. However, low rectal cancer resection with sphincter preservation may lead to a positive distal resection margin (DRM), with a high risk for local recurrence. Confocal laser endomicroscopy (CLE) enables the real-time, in vivo optical biopsy of living tissue. Real-time in vivo probe-based CLE examination can provide optical biopsy and is feasible and safe for selecting the DRM during TaTME for low rectal cancer.