TY - JOUR
T1 - A Phase II Clinical Trial to Study the Safety of Triamcinolone after Endoscopic Radial Incision and Cutting Dilatation for Benign Stenosis of the Lower Gastrointestinal Tract
T2 - A Study Protocol
AU - Moroi, Rintaro
AU - Shiga, Hisashi
AU - Nochioka, Kotaro
AU - Chiba, Hirofumi
AU - Shimoyama, Yusuke
AU - Onodera, Motoyuki
AU - Naito, Takeo
AU - Tosa, Masaki
AU - Kakuta, Yoichi
AU - Sato, Yuichiro
AU - Kayaba, Shoichi
AU - Takahashi, Seichi
AU - Miyata, Satoshi
AU - Kinouchi, Yoshitaka
AU - Masamune, Atsushi
N1 - Publisher Copyright:
© 2023, Kurume University School of Medicine. All rights reserved.
PY - 2023
Y1 - 2023
N2 - Summary: Background: Lower gastrointestinal tract stenosis is commonly diagnosed and is typically treated with surgery or endoscopic balloon dilation (EBD). Radial incision and cutting (RIC) is a novel treatment approach that has several benefits compared with EBD and surgery. Although RIC has demonstrated a high technical success rate and has been shown to improve subjective symptoms, previous studies revealed that restenosis after RIC remain unsolved. Herein, we report the design of a prospective, multicenter, single-arm, interventional, phase II trial to evaluate the safety of local triamcinolone acetonide (TA) administration and its feasibility in preventing restenosis after RIC for lower gastrointestinal tract stenosis. Methods: The major inclusion criteria are age 20–80 years and the presence of benign stenosis in the lower gastrointestinal tract accessible by colonoscope. We will perform RIC followed by local administration of TA to 20 participants. The primary outcome is the safety of local TA administration, which will be assessed by determining the frequency of adverse events of special interest. The secondary outcomes are the technical success rate of RIC, duration of procedure, improvement in subjective symptoms, and duration of hospitalization. The outcomes, improvement in subjective symptoms, and long-term results will be evaluated using descriptive statistics, Student’s t-test, and Kaplan–Meier curve, respectively. Discussion: This explorative study will provide useful information regarding the safety of TA administration after RIC, which may contribute to further investigations.
AB - Summary: Background: Lower gastrointestinal tract stenosis is commonly diagnosed and is typically treated with surgery or endoscopic balloon dilation (EBD). Radial incision and cutting (RIC) is a novel treatment approach that has several benefits compared with EBD and surgery. Although RIC has demonstrated a high technical success rate and has been shown to improve subjective symptoms, previous studies revealed that restenosis after RIC remain unsolved. Herein, we report the design of a prospective, multicenter, single-arm, interventional, phase II trial to evaluate the safety of local triamcinolone acetonide (TA) administration and its feasibility in preventing restenosis after RIC for lower gastrointestinal tract stenosis. Methods: The major inclusion criteria are age 20–80 years and the presence of benign stenosis in the lower gastrointestinal tract accessible by colonoscope. We will perform RIC followed by local administration of TA to 20 participants. The primary outcome is the safety of local TA administration, which will be assessed by determining the frequency of adverse events of special interest. The secondary outcomes are the technical success rate of RIC, duration of procedure, improvement in subjective symptoms, and duration of hospitalization. The outcomes, improvement in subjective symptoms, and long-term results will be evaluated using descriptive statistics, Student’s t-test, and Kaplan–Meier curve, respectively. Discussion: This explorative study will provide useful information regarding the safety of TA administration after RIC, which may contribute to further investigations.
KW - endoscopic dilation
KW - radial incision and cutting
KW - triamcinolone acetonide
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U2 - 10.2739/KURUMEMEDJ.MS7012005
DO - 10.2739/KURUMEMEDJ.MS7012005
M3 - Article
C2 - 38508736
AN - SCOPUS:85197972279
SN - 0023-5679
VL - 70
SP - 53
EP - 60
JO - Kurume Medical Journal
JF - Kurume Medical Journal
IS - 1-2
ER -