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.

Study Overview

• Status: Completed
• Conditions: Colonic Diseases; Occlusion; Stricture
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful stent placement	On the first attempt with complete deployment and precise positioning of the stent at the location of the stenosis, which was confirmed by fluoroscopy	Immediatly after stent insertion (one minute)
Successful stent retrieval	Possibility of retrieval the stent with a snare or a forceps	One minute (during colonoscopy for stent retrieval)
Occurrence of any complication during interventional endoscopy, stent retrieval and the follow-up	Perforation, bleeding, migration, pain, fecal incontinence and foreign body sensation, stent impaction and hyperplastic tissue overgrowth	60 days
Recurrence of colonic occlusion	New episode of occlusion or subocclusion (pain with stool and gas discontinuation and imaging with cecum dilation) after stent retrieval or migration	60 days, 6 months and one year

Collaborators and Investigators

• Sponsor: Société Française d'Endoscopie Digestive
• Investigators: Principal Investigator: Geoffroy Vanbiervliet, MD, Société Française d'Endoscopie Digestive

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 4, 2012
• Last Update Submitted That Met QC Criteria: March 30, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: colon; Covered metallic stent; benign stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Colonic Diseases
• Other Study ID Numbers: FCSEMS