Covered Metallic Stent and Benign Colonic Strictures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VANBIERVLIET, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier:
NCT01570114
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Société Française d'Endoscopie Digestive:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

Patients in universitary tertiary care center benefited from a fully covered metallic colonic stent for treatment of benign stricture

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01570114

Sponsors and Collaborators
Société Française d'Endoscopie Digestive
Investigators
Principal Investigator: Geoffroy Vanbiervliet, MD Société Française d'Endoscopie Digestive
  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 July 20, 2014