Covered Metallic Stent and Benign Colonic Strictures

NCT ID: NCT01570114

Last Updated: 2012-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-10-31

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.

Conditions

Colonic Diseases; Stricture; Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

covered metallic stent

Endoscopically insertion of fully covered metallic stent on benign colonic strictures

Fully covered metallic colonic stent

Intervention Type: DEVICE

Endoscopically insertion of fully covered metallic colonic stent

Interventions

Fully covered metallic colonic stent

Endoscopically insertion of fully covered metallic colonic stent

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Française d'Endoscopie Digestive

OTHER

Sponsor Role: lead

Responsible Party

VANBIERVLIET

Medical doctor - study coordinator and director of the endoscopy unit in universitary hospital of Nice (France)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geoffroy Vanbiervliet, MD

Role: PRINCIPAL_INVESTIGATOR

Société Française d'Endoscopie Digestive

Other Identifiers

FCSEMS

Identifier Type: -

Identifier Source: org_study_id