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

March 29, 2012
March 30, 2012
January 2011
September 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01570114 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Covered Metallic Stent and Benign Colonic Strictures
EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Colonic Diseases
  • Stricture
  • Occlusion
Device: Fully covered metallic colonic stent
Endoscopically insertion of fully covered metallic colonic stent
covered metallic stent
Endoscopically insertion of fully covered metallic stent on benign colonic strictures
Intervention: Device: Fully covered metallic colonic stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
October 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01570114
FCSEMS
No
VANBIERVLIET, Société Française d'Endoscopie Digestive
Société Française d'Endoscopie Digestive
Not Provided
Principal Investigator: Geoffroy Vanbiervliet, MD Société Française d'Endoscopie Digestive
Société Française d'Endoscopie Digestive
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP