Clinical trial NCT01570114: Covered Metallic Stent and Benign Colonic Strictures
Official title: EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Diseases
Stricture
Occlusion
Keywords: Covered metallic stent
colon
benign stricture
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Symptom resolution of colonic occlusion
timeFrame: 48 hours
Secondary outcomes:
measure: Successful stent placement
timeFrame: Immediatly after stent insertion (one minute)
measure: Successful stent retrieval
timeFrame: One minute (during colonoscopy for stent retrieval)
measure: Occurrence of any complication during interventional endoscopy, stent retrieval and the follow-up
timeFrame: 60 days
measure: Recurrence of colonic occlusion
timeFrame: 60 days, 6 months and one year
Other outcomes:
Locations:
Study officials:
affiliation: Société Française d'Endoscopie Digestive
name: Geoffroy Vanbiervliet, MD
role: PRINCIPAL_INVESTIGATOR
References: