Randomized Controlled Trial
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 21, 2020; 26(39): 6098-6110
Published online Oct 21, 2020. doi: 10.3748/wjg.v26.i39.6098
Impact of cap-assisted colonoscopy during transendoscopic enteral tubing: A randomized controlled trial
Fa-Ming Zhang, Hong Yin, Deng-Chyang Wu, Wen-Hung Hsu, Da Lin, Yu Yuan, Hua Tu, Lu Wei, Min Zhong, Xia Wu, Pan Li, Bo-Ta Cui, Kang-Jian Liu, Quan Wen
Quan Wen, Kang-Jian Liu, Bo-Ta Cui, Pan Li, Xia Wu, Min Zhong, Lu Wei, Fa-Ming Zhang, Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China
Hua Tu, Department of Spleen and Stomach Diseases, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, Hubei Province, China
Yu Yuan, Da Lin, Department of Gastroenterology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou 510080, Guangdong Province, China
Wen-Hung Hsu, Deng-Chyang Wu, Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan
Hong Yin, Department of Gastroenterology, Zigong Fourth People’s Hospital, Zigong 643000, Sichuan Province, China
Author contributions: Wen Q and Liu KJ equally contributed to this work; Zhang FM contributed to the design of the research; Wen Q, Liu KJ, Cui BT, Li P, Wu X, Zhong M, Wei L, Tu H, Yuan Y, Lin D, Hsu WH, Wu DC, Yin H, and Zhang FM performed the research; Wen Q and Liu KJ analyzed the data; Wen Q drafted the manuscript; All authors read and approved the final manuscript.
Supported by the public donated Intestine Initiative Foundation; Jiangsu Province Creation Team and Leading Talents Project; National Natural Science Foundation of China, No. 81670495, No. 81600417; and Top-notch Talent Research Projects, No. LGY2017080.
Institutional review board statement: The study was reviewed and approved by the Second Affiliated Hospital of Nanjing Medical University Institutional Review Board on October 10, 2017, and subsequently by all the other participating centers.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT03621033.
Informed consent statement: All study participants, or their legal guardians, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Zhang FM conceived the concept of transendoscopic enteral tubing and the related device. Other authors declare that they have no competing interests.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: We 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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Fa-Ming Zhang, MD, PhD, Doctor, Professor, Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, No. 121 Jiangjiayuan, Nanjing 210011, Jiangsu Province, China. fzhang@njmu.edu.cn
Received: May 20, 2020
Peer-review started: May 19, 2020
First decision: May 29, 2020
Revised: June 2, 2020
Accepted: September 1, 2020
Article in press: September 1, 2020
Published online: October 21, 2020
Abstract
BACKGROUND

Colonic transendoscopic enteral tubing (TET) requires double cecal intubation, raising a common concern of how to save cecal intubation time and make the tube stable. We hypothesized that cap-assisted colonoscopy (CC) might reduce the second cecal intubation time and bring potential benefits during the TET procedure.

AIM

To investigate if CC can decrease the second cecal intubation time compared with regular colonoscopy (RC).

METHODS

This prospective multicenter, randomized controlled trial was performed at four centers. Subjects ≥ 7 years needing colonic TET were recruited from August 2018 to January 2020. All subjects were randomly assigned to two groups. The primary outcome was the second cecal intubation time. Secondary outcomes included success rate, insertion pain score, single clip fixation time, purpose and retention time of TET tube, length of TET tube inserted into the colon, and all procedure-related (serious) adverse events.

RESULTS

A total of 331 subjects were randomized to the RC (n = 165) or CC (n = 166) group. The median time of the second cecal intubation was significantly shorter for CC than RC (2.2 min vs 2.8 min, P < 0.001). In patients with constipation, the median time of second cecal intubation in the CC group (n = 50) was shorter than that in the RC group (n = 43) (2.6 min vs 3.8 min, P = 0.004). However, no difference was observed in the CC (n = 42) and RC (n = 46) groups of ulcerative colitis patients (2.0 min vs 2.5 min, P = 0.152). The insertion pain score during the procedure in CC (n = 14) was lower than that in RC (n = 19) in unsedated colonoscopy (3.8 ± 1.7 vs 5.4 ± 1.9; P = 0.015). Multivariate analysis revealed that only CC (odds ratio [OR]: 2.250, 95% confidence interval [CI]: 1.161-4.360; P = 0.016) was an independent factor affecting the second cecal intubation time in difficult colonoscopy. CC did not affect the colonic TET tube’s retention time and length of the tube inserted into the colon. Moreover, multivariate analysis found that only endoscopic clip number (OR: 2.201, 95%CI: 1.541-3.143; P < 0.001) was an independent factor affecting the retention time. Multiple regression analysis showed that height (OR: 1.144, 95%CI: 1.027-1.275; P = 0.014) was the only independent factor influencing the length of TET tube inserted into the colon in adults.

CONCLUSION

CC for colonic TET procedure is a safe and less painful technique, which can reduce cecal intubation time.

Keywords: Transendoscopic enteral tube, Endoscopy, Colonoscopy, Fecal microbiota transplant, Washed microbiota transplant, Colon

Core Tip: The design of colonic transendoscopic enteral tubing (TET) requires repeated colonoscopies, which increase procedure time and potential procedure-related risk. This multicenter, prospective, randomized controlled trial explored whether cap-assisted colonoscopy (CC) can decrease the second cecal intubation time and has potential benefits compared with regular colonoscopy during the TET procedure. Our findings show that CC can decrease the second cecal intubation time during the TET procedure, especially for difficult colonoscopy. Moreover, CC for colonic TET can reduce the insertion pain score in unsedated colonoscopy and does not affect the safety and stability of the TET tube.