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OpenTrials
Completed

NCT Number: NCT04718493

Endoscopic Stenting in Crohn Related Strictures

Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.

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Key information

Conditions

Intestinal Strictures Related to Crohn´s Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Benign high-grade Crohn stricture

Exclusion criteria

  • Unwillingness to participate
  • Planned surgery
  • High risk for bleeding

Treatment and study plan

Self-expandable metal stent

Procedure

Endoscopic stenting of intestinal stricture related to Crohn´s disease

Balloon dilatation

Procedure

Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease

Primary outcomes

  1. Technical success rate

    Time frame: Peroperative

  2. Adverse event rate

    Time frame: Within 7 days

Secondary outcomes

  1. Clinical success rate

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jun 28, 2023

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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