Covered Metallic Stent and Benign Colonic Strictures
|ClinicalTrials.gov Identifier: NCT01570114|
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : April 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colonic Diseases Stricture Occlusion||Device: Fully covered metallic colonic stent||Phase 2|
It is a national multicentric retrospective study on the use of fully covered metal stent placement in patients with benign colorectal strictures.
Consecutive patients above 18 years of age with a symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy and which required the use of a FCSEMS were included. All strictures were confirmed to be benign by histology. All details concerning previous history, origins and treatment (medical or endoscopic) of the colonic stenosis were collected from the medical file.
Senior endoscopists with an experience of more than 50 colonic stent placements performed the procedure under general propofol-induced anesthesia with the same technic (The stent was placed under fluoroscopic and videoendoscopic controls).
Patients were required after the procedure to take oral osmotic laxatives regularly. Post-stenting complications were defined as immediate (during the procedure), early (occurring ≤ 30 days) and late (> 30 days) after the procedure. Stent removal and routine follow up endoscopy were scheduled 4 to 6 weeks after placement in most patients or earlier if complications occurred.
All patients were followed up at regular intervals based on their clinical situation. A retrospective chart review was performed to analyze the long-term outcome of the patients.
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||October 2011|
covered metallic stent
Endoscopically insertion of fully covered metallic stent on benign colonic strictures
Device: Fully covered metallic colonic stent
Endoscopically insertion of fully covered metallic colonic stent
- Symptom resolution of colonic occlusion [ Time Frame: 48 hours ]Defined as the clinical (stools, stop pain) and radiological evidence of colonic decompression within 48 hours of stent insertion and without the need for reintervention
- Successful stent placement [ Time Frame: Immediatly after stent insertion (one minute) ]On the first attempt with complete deployment and precise positioning of the stent at the location of the stenosis, which was confirmed by fluoroscopy
- Successful stent retrieval [ Time Frame: One minute (during colonoscopy for stent retrieval) ]Possibility of retrieval the stent with a snare or a forceps
- Occurrence of any complication during interventional endoscopy, stent retrieval and the follow-up [ Time Frame: 60 days ]Perforation, bleeding, migration, pain, fecal incontinence and foreign body sensation, stent impaction and hyperplastic tissue overgrowth
- Recurrence of colonic occlusion [ Time Frame: 60 days, 6 months and one year ]New episode of occlusion or subocclusion (pain with stool and gas discontinuation and imaging with cecum dilation) after stent retrieval or migration
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570114
|Principal Investigator:||Geoffroy Vanbiervliet, MD||Société Française d'Endoscopie Digestive|