Covered Metallic Stent and Benign Colonic Strictures
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Symptom resolution of colonic occlusion [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
Secondary Outcome Measures
- Successful stent placement [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 [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 [60 days]
Perforation, bleeding, migration, pain, fecal incontinence and foreign body sensation, stent impaction and hyperplastic tissue overgrowth
- Recurrence of colonic occlusion [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients above 18 years of age
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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
Locations
No locations specified.Sponsors and Collaborators
- Société Française d'Endoscopie Digestive
Investigators
- Principal Investigator: Geoffroy Vanbiervliet, MD, Société Française d'Endoscopie Digestive
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FCSEMS