An evaluation of safety and efficacy of triamcinolone acetonide for preventing re-stenosis in endoscopic radial incision and cutting dilatio

Not Applicable

Recruiting

• Conditions: benign stenosis of lower gastrointestinal tract; stenosis of gastrointestinal tract

• Registration Number: JPRN-jRCTs021220004
• Lead Sponsor: Moroi Rintaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

(1) any gender patients aged between 20 and 80
(2) patients with benign stenosis of lower gastroint estinal tract and with indication of RIC
(3) Performance Status is between 0 and 2
(4) patients with a written infromed consent for attending the study

Exclusion Criteria

(1) the stenosis whch is over 2 cm
(2) abscss or fistula closed to the stensis
(3) edematous stenosis, not fibrotic stenosis
(4) malignant stenosis
(5) patients who are suspected with thin wall in the stenosis site diagnosed by abdominal ultrasound and MR enterography
(6) patients with hypersensitivity to triamcinolone acetonide, with administration of desmopressin acetate hydrate, and with infeciton including fungs, tuberculosis and herpes simplex keratitis
(7) with anti-coagulant or anti-platelet drugs that are not allowed to stop temporaly
(8) pregnancy (including suspicious cases), or with in 28 days after childbirth, or lactation
(9) with psychiatric disease
(10) with severe cardio-pulmonary disease
(11) the patinet that lead doctor considered inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety during two months after RIC with local administration of triamcinolone acetonide

Secondary Outcome Measures

Name	Time	Method
scopre passage at the dilation site two months after RIC with local administaration of triamcinolone acetonide, technical success rate (defined as the scope passage just after the RIC), evaluation of subjective symptom using VAS(visual analog scale) and CDAI(Crohn's disease activity index), duration of hospitalization, procedure time.