An invetigation of radial incision and cutting for stenosis of small intestine using Flushknife long type.

JRCT ID: jRCTs022200040

Registered date:01/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: benign small bowel stenosis
• Date of first enrollment: 15/10/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Endoscopic dilation for small intestine through RIC (Radial Incision and Cutting) method using Flushknife BTS.

Outcome(s)

Primary Outcome

Technical success rate.
The technical success is defined as the scope passage just after the RIC procedure

• Secondary Outcome: adverse event, evaluation of subjective symptom using VAS(visual analog scale), duration of hospitalization, procedure time. CDAI(Crohn's disease activity index)

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 small bowel stenosis
(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) with anti-coagulant or anti-platelet drugs that are not allowed to stop temporaly
(6) pregnancy (including suspicious cases), or within 28 days after childbirth, or lactation
(7) with psychiatric disease
(8) with severe cardio-pulmonary disease
(9) the patinet that lead doctor considered inappropriate

Related Information

• Primary Sponsor: Moroi Rintaro