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Completed

NCT Number: NCT01570114

Covered Metallic Stent and 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.

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Key information

Conditions

Colonic Diseases Bites and Stings Chemically-Induced Disorders Constriction, Pathologic Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Occlusion Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Poisoning Stricture Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fully covered metallic colonic stent

Device

Endoscopically insertion of fully covered metallic colonic stent

Primary outcomes

  1. Symptom resolution of colonic occlusion

    Time frame: 48 hours

    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

Secondary outcomes

  1. Successful stent placement

    Time frame: Immediatly after stent insertion (one minute)

    On the first attempt with complete deployment and precise positioning of the stent at the location of the stenosis, which was confirmed by fluoroscopy

  2. Successful stent retrieval

    Time frame: One minute (during colonoscopy for stent retrieval)

    Possibility of retrieval the stent with a snare or a forceps

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

    Time frame: 60 days

    Perforation, bleeding, migration, pain, fecal incontinence and foreign body sensation, stent impaction and hyperplastic tissue overgrowth

  4. Recurrence of colonic occlusion

    Time frame: 60 days, 6 months and one year

    New episode of occlusion or subocclusion (pain with stool and gas discontinuation and imaging with cecum dilation) after stent retrieval or migration

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 4, 2012
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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