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
Quan Wen, Kang-Jian Liu, Bo-Ta Cui, Pan Li, Xia Wu, Min Zhong, Lu Wei, Hua Tu, Yu Yuan, Da Lin, Wen-Hung Hsu, Deng-Chyang Wu, Hong Yin, Fa-Ming Zhang
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
Research background

The design of colonic transendoscopic enteral tubing (TET) requires repeated colonoscopies, which increase procedure time and potential procedure-related risks. It is uncertain whether cap-assisted colonoscopy (CC) would facilitate the technical performance after inserting the TET tube into the intestinal lumen during the TET procedure.

Research motivation

We conducted a multicenter, prospective, and randomized controlled trial to ascertain whether CC could decrease the second cecal intubation time and bring potential benefits compared with regular colonoscopy (RC) during TET.

Research objectives

The aim of this study was to compare CC with RC in the second cecal intubation time among subjects undergoing colonic TET.

Research methods

This 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 the RC (n = 165) or CC (n = 166) group. Baseline characteristics including age, sex, body mass index, previous abdominal or pelvic surgery, and disease category were collected before colonic TET. The primary outcome was the second cecal intubation time. The secondary outcomes included TET success rate, maximum insertion pain score, single clip fixation time, purpose and retaining time of TET tube, length of TET tube inserted into the colon, and all procedure-related (serious) adverse events.

Research results

The median time of the second cecal intubation was significantly shorter for the CC group than RC (2.2 min vs 2.8 min; P < 0.001). In constipation patients, the median time of the second cecal intubation in group of CC (n = 50) was shorter than RC (n = 43) (2.6 min vs 3.8 min; P = 0.004). However, no difference was observed in the groups of CC (n = 42) and RC (n = 46) in ulcerative colitis patients (2.0 min vs 2.5 min; P = 0.152). The insertion pain score during the procedure in the group of CC (n = 14) was lower than that in RC (n = 19) in unsedated colonoscopies (3.8 ± 1.7 vs 5.4 ± 1.9; P = 0.015). Multivariate analysis revealed that only CC (OR = 2.250, 95%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 retention time and the 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. 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 by multiple regression analysis.

Research conclusions

CC for the colonic TET procedure is a safe and less painful technique which is able to save the cecal intubation time. Importantly, CC does not affect the safety and stability of the TET tube.

Research perspectives

Further studies are needed in children aged 3-7 years and the Western population.