ileo-colonic anastomotic stricture related to Crohn's diseaae lower gastointestinal tract stenosis, Crohn's diasese, metallic stent
Conditions
Interventions
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.
Sponsors
Moroi Rintaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of adverse event of special interest ( delayed bleeding, perforation) from stent insertion to one week after endoscopic removal of metallic stent | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 The rate of re-stenosis, re-intervention and surgery | — |
Contacts
Public ContactRintaro Moroi
Tohoku University Hospital
Outcome results
None listed