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

JRCT ID: jRCTs021220004

Registered date:21/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: benign stenosis of lower gastrointestinal tract
• Date of first enrollment: 21/04/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Endoscopic dilation for benign stenosis of lower gastrointestinal tract through RIC (Radial Incision and Cutting) method with local administration of triamcinolone acetonide

Outcome(s)

• Primary Outcome: safety during two months after RIC with local administration of triamcinolone acetonide
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Moroi Rintaro