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

An evaluation of safety of triamcinolone and postoperative re-stenosis in endoscopic radial incision and cutting dilatation for benign stenosis of lower gastrointestinal tract: A multicenter interventional trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021220004
Enrollment
20
Registered
2022-04-21
Start date
2022-04-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign stenosis of lower gastrointestinal tract stenosis of gastrointestinal tract

Interventions

Endoscopic dilation for benign stenosis of lower gastrointestinal tract through RIC (Radial Incision and Cutting) method with local administration of triamcinolone acetonide
Radial Incision and Cutting dilation, triamcinolone acetonide

Sponsors

Moroi Rintaro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
safety during two months after RIC with local administration of triamcinolone acetonide

Secondary

MeasureTime frame
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, time to re-stenosis, re-intervention and surgery

Contacts

Public ContactRintaro Moroi

Tohoku University Hospital

rinta@med.tohoku.ac.jp+81-22-717-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026