Covered Metallic Stent and Benign Colonic Strictures

Colonic Diseases Clinical Trial

Official title:

EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570114
• Other study ID #: FCSEMS
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2012
• Last updated: March 30, 2012
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colonic Diseases
• Constriction, Pathologic
• Occlusion
• Stricture

Intervention

Device:
• Fully covered metallic colonic stent
Endoscopically insertion of fully covered metallic colonic stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	Successful stent retrieval	Possibility of retrieval the stent with a snare or a forceps	One minute (during colonoscopy for stent retrieval)	No
Secondary	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	Yes
Secondary	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	No