Covered Metallic Stent and Benign Colonic Strictures
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Purpose
Self-expanding metallic stent placement is a safe and effective endoscopic procedure increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages over non-covered stents, including the possibility of retrieval and limited local tissue reaction, while providing alleviation of obstruction at possibly lower costs. Only few reports of fully covered metal stent placement in patients with benign colorectal strictures are available in the literature. The aim of this study was to assess the effectiveness of FCSEMS in the management of the colonic benign strictures.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonic Diseases Stricture Occlusion |
Device: Fully covered metallic colonic stent |
Phase 2 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES |
- Symptom resolution of colonic occlusion [ Time Frame: 48 hours ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]New episode of occlusion or subocclusion (pain with stool and gas discontinuation and imaging with cecum dilation) after stent retrieval or migration
| Enrollment: | 43 |
| Study Start Date: | January 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients in universitary tertiary care center benefited from a fully covered metallic colonic stent for treatment of benign stricture
Inclusion Criteria:
- patients above 18 years of age
- symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy
Exclusion Criteria:
- Previous insertion or treatment of the stricture with metallic (covered or uncovered) stent
Contacts and Locations More Information
No publications provided
| Responsible Party: | VANBIERVLIET, Medical doctor - study coordinator and director of the endoscopy unit in universitary hospital of Nice (France), Société Française d'Endoscopie Digestive |
| ClinicalTrials.gov Identifier: | NCT01570114 History of Changes |
| Other Study ID Numbers: | FCSEMS |
| Study First Received: | March 29, 2012 |
| Last Updated: | March 30, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Société Française d'Endoscopie Digestive:
|
Covered metallic stent colon benign stricture |
Additional relevant MeSH terms:
|
Colonic Diseases Intestinal Obstruction Constriction, Pathologic Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013