An investigation of metallic stent insertion for anastomotic strictures related to Crohn's disease

JRCT ID: jRCTs022240024

Registered date:18/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: ileo-colonic anastomotic stricture related to Crohn's diseaae
• Date of first enrollment: 18/09/2024
• Target sample size: 5
• Study type: Interventional

Intervention(s)

Insertion of metallic stent for ileo-colonic anastomotic stenosis following surgery related to Crohn's disease.
Endoscopic removal of stent at one week following stent insertion.

Outcome(s)

• Primary Outcome: The ratio of adverse event of special interest ( delayed bleeding, perforation) from stent insertion to one week after endoscopic removal of metallic stent

Secondary Outcome

adverse event other than AESI,
technical success rate of stent insertion,
migration rates of stent,
technical success rates of removal of stent,
passage rate of colonoscopy after stent removal
imprpvement of subjective symptoms using visual analog scale
duration of hospital stay (from stent insertion to discharge)
procedure time of stent insertion

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Adults aged 18 to 80 who have given written consent for participation in the study.
(2) Patients with benign strictures (stenosis length is 5cm or less) at the ileocolonic anastomosis after intestinal surgery for Crohn's disease, who have a history of previous endoscopic dilation procedures (balloon dilation, RIC, etc.) (not including history of procedures for stenoses other than anastomotic stenoses).
(3) Patients with subjective symptoms such as abdominal distention, abdominal pain, difficulty in defecation, nausea, or any other symptoms presumed to be caused by intestinal stenosis
(4) Patients who are capable of outpatient visits (PS: 0-2).
(5) Patients who have provided written consent to participate in this clinical study of their own free will.

Exclude criteria

(1)Patients whose stenosis length exceeds the effective length of the stent (stenosis length is evaluated by fluoroscopic endoscopy with contrast enhanced by gastrografin)
(2)With surgical lesion such as stenosis or abscess near the stenosis (surgery is prioritozed)
(3)Thin wall at the stenosis site evaluated by ultra sound, computed tomography or magnetic resonance imaging
(4)No drug withdrawal possible of anti-platelet drug and anti-coagulant drug
(5)Woman with pregnancy, possibility of pregnancy.
(6)With psychiatric disorder
(7)With severe cardiopulmonary disorder
(8)The patients who the doctor judged as inappropriate.

Related Information

• Primary Sponsor: Rintaro Moroi