Endoscopic Stenting in Crohn Related Strictures

NCT ID: NCT04718493

Last Updated: 2023-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal Strictures Related to Crohn´s Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stent

Group Type EXPERIMENTAL

Self-expandable metal stent

Intervention Type PROCEDURE

Endoscopic stenting of intestinal stricture related to Crohn´s disease

Dilatation

Group Type ACTIVE_COMPARATOR

Balloon dilatation

Intervention Type PROCEDURE

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

Interventions

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Self-expandable metal stent

Endoscopic stenting of intestinal stricture related to Crohn´s disease

Intervention Type PROCEDURE

Balloon dilatation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Benign high-grade Crohn stricture

Exclusion Criteria

* Unwillingness to participate
* Planned surgery
* High risk for bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Per Hedenström

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per-Ove Stotzer, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

References

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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.

Reference Type DERIVED
PMID: 33722805 (View on PubMed)

Other Identifiers

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Project database VGR 95381

Identifier Type: -

Identifier Source: org_study_id

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