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Covered Metallic Stent and Benign Colonic Strictures

EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01570114
Enrollment
43
Registered
2012-04-04
Start date
2011-01-31
Completion date
2011-10-31
Last updated
2012-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diseases, Occlusion, Stricture

Keywords

Covered metallic stent, colon, benign stricture

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.

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.

Interventions

DEVICEFully covered metallic colonic stent

Endoscopically insertion of fully covered metallic colonic stent

Sponsors

Société Française d'Endoscopie Digestive
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Symptom resolution of colonic occlusion48 hoursDefined 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

MeasureTime frameDescription
Successful stent placementImmediatly 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 retrievalOne 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-up60 daysPerforation, bleeding, migration, pain, fecal incontinence and foreign body sensation, stent impaction and hyperplastic tissue overgrowth
Recurrence of colonic occlusion60 days, 6 months and one yearNew episode of occlusion or subocclusion (pain with stool and gas discontinuation and imaging with cecum dilation) after stent retrieval or migration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026