A pilot study investigating the safety and feasibility of endoscopic dilation using a radial incision and cutting technique for benign strictures of the small intestine: a study protocol.
Endoscopic dilation
Radial incision and cutting
Small bowel stenosis
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
19 Apr 2022
19 Apr 2022
Historique:
received:
05
03
2021
accepted:
06
04
2022
entrez:
20
4
2022
pubmed:
21
4
2022
medline:
21
4
2022
Statut:
epublish
Résumé
Small benign intestinal stenosis is usually treated by endoscopic balloon dilation (EBD) or surgery. Although EBD and surgery are able to resolve the stenosis in most cases, they are associated with several problems such as insufficient dilation and surgical stress, respectively. On the contrary, a novel approach called radial incision and cutting (RIC) is reported to have several benefits when compared to EBD and surgery. We can currently adopt RIC only for the strictures in the colon or terminal ileum and not for those stenotic lesions present further in the small intestine where balloon-assisted endoscopy is utilized, because the long-type electric knife is currently not approved for use in Japan. We will herein conduct a pilot study to investigate the safety and feasibility of RIC for treating the benign stenoses of the small intestine using the long-type electric knife. This will be a single-center, single-arm, interventional trial. The major criteria for inclusion will be age ranging from 20 to 80 years and the presence of benign stenosis in the small intestine. We will perform RIC on 10 participants. The primary outcome is the safety of this procedure, which will be assessed by measuring the frequency of adverse events of special interest. The secondary outcomes will be technical success rate, improvement in subjective symptoms, procedure time, and duration of hospitalization. This pilot study will provide useful information that will aid in adopting RIC for treating the benign strictures present in the small intestine. jRCT Identifier, jRCTs022200040 . Registered on 1 March 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Small benign intestinal stenosis is usually treated by endoscopic balloon dilation (EBD) or surgery. Although EBD and surgery are able to resolve the stenosis in most cases, they are associated with several problems such as insufficient dilation and surgical stress, respectively. On the contrary, a novel approach called radial incision and cutting (RIC) is reported to have several benefits when compared to EBD and surgery. We can currently adopt RIC only for the strictures in the colon or terminal ileum and not for those stenotic lesions present further in the small intestine where balloon-assisted endoscopy is utilized, because the long-type electric knife is currently not approved for use in Japan. We will herein conduct a pilot study to investigate the safety and feasibility of RIC for treating the benign stenoses of the small intestine using the long-type electric knife.
METHODS
METHODS
This will be a single-center, single-arm, interventional trial. The major criteria for inclusion will be age ranging from 20 to 80 years and the presence of benign stenosis in the small intestine. We will perform RIC on 10 participants. The primary outcome is the safety of this procedure, which will be assessed by measuring the frequency of adverse events of special interest. The secondary outcomes will be technical success rate, improvement in subjective symptoms, procedure time, and duration of hospitalization.
DISCUSSION
CONCLUSIONS
This pilot study will provide useful information that will aid in adopting RIC for treating the benign strictures present in the small intestine.
TRIAL REGISTRATION
BACKGROUND
jRCT Identifier, jRCTs022200040 . Registered on 1 March 2021.
Identifiants
pubmed: 35440064
doi: 10.1186/s40814-022-01046-8
pii: 10.1186/s40814-022-01046-8
pmc: PMC9017048
doi:
Types de publication
Journal Article
Langues
eng
Pagination
85Informations de copyright
© 2022. The Author(s).
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