NCT04718493

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

3.9 years

First QC Date

January 18, 2021

Last Update Submit

June 27, 2023

Conditions

Intestinal Strictures Related to Crohn´s Disease

Outcome Measures

Primary Outcomes (2)

  • Technical success rate

    Peroperative

  • Adverse event rate

    Within 7 days

Secondary Outcomes (1)

  • Clinical success rate

    24 months

Study Arms (2)

Stent

EXPERIMENTAL
Procedure: Self-expandable metal stent

Dilatation

ACTIVE COMPARATOR
Procedure: Balloon dilatation

Interventions

Self-expandable metal stentPROCEDURE

Endoscopic stenting of intestinal stricture related to Crohn´s disease

Stent
Balloon dilatationPROCEDURE

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

Dilatation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Benign high-grade Crohn stricture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hedenstrom P, Stotzer PO. Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study. BMJ Open Gastroenterol. 2021 Mar;8(1):e000612. doi: 10.1136/bmjgast-2021-000612.

    PMID: 33722805DERIVED

MeSH Terms

Interventions

Self Expandable Metallic Stents

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Per-Ove Stotzer, Ass Prof

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 22, 2021

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

May 1, 2020

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share