Covered Metallic Stent and Benign Colonic Strictures

NCT01570114 | Completed

• 1 other identifier: FCSEMS
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonic Diseases; Stricture; Occlusion

Keywords

Covered metallic stent; colon; benign stricture

Outcome Measures

Primary Outcomes (1)

• Symptom resolution of colonic occlusion

  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

  48 hours

Secondary Outcomes (4)

• Successful stent placement

  Immediatly after stent insertion (one minute)

• Successful stent retrieval

  One minute (during colonoscopy for stent retrieval)

• Occurrence of any complication during interventional endoscopy, stent retrieval and the follow-up

  60 days

• Recurrence of colonic occlusion

  60 days, 6 months and one year

Study Arms (1)

covered metallic stent

Endoscopically insertion of fully covered metallic stent on benign colonic strictures

Device: Fully covered metallic colonic stent

Interventions

Fully covered metallic colonic stent DEVICE

Endoscopically insertion of fully covered metallic colonic stent

covered metallic stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patients above 18 years of age
• symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy

You may not qualify if:

• Previous insertion or treatment of the stricture with metallic (covered or uncovered) stent

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

MeSH Terms

Conditions

Colonic Diseases; Constriction, Pathologic; Bites and Stings

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Geoffroy Vanbiervliet, MD

  Société Française d'Endoscopie Digestive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor - study coordinator and director of the endoscopy unit in universitary hospital of Nice (France)

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 4, 2012
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-03