NCT03735355

Brief Summary

There is currently no standard management to guide the clinicians in treating patients with fibrostenotic disease. European Crohns and Colitis Organization \[ECCO\] recently developed a topical review on prediction, diagnosis and management of fibrostenosing Crohns disease. The review suggests endoscopic balloon dilation, strictureplasty, and intestinal resection as reasonable treatment options for short strictures based on the low grade of evidence.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

November 5, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

2.2 years

First QC Date

November 5, 2018

Last Update Submit

November 6, 2018

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Surgery-free period in patients with fibrostenotic Crohns disease

    The time to the need for first surgical treatment in following study intervention in each group

    2 years

Study Arms (2)

Balloon dilation

EXPERIMENTAL

TTS balloon dilation

Procedure: TTS balloon dilation

Surgery

ACTIVE COMPARATOR

Resection of the fibrostenotic area

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Surgical resection of fibrostenotic area

Surgery
TTS balloon dilationPROCEDURE

Dilation of a stricture using TTS balloon

Balloon dilation

Eligibility Criteria

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

You may qualify if:

  • Patients with Crohns disease and a short stricture (\<5 cm) within the reach of upper or lower GI endoscopy

You may not qualify if:

  • Abscess or phlegmon
  • Fistula
  • High-grade dysplasia
  • Malignancy
  • Previous intervention
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rieder F, Latella G, Magro F, Yuksel ES, Higgins PD, Di Sabatino A, de Bruyn JR, Rimola J, Brito J, Bettenworth D, van Assche G, Bemelman W, d'Hoore A, Pellino G, Dignass AU. European Crohn's and Colitis Organisation Topical Review on Prediction, Diagnosis and Management of Fibrostenosing Crohn's Disease. J Crohns Colitis. 2016 Aug;10(8):873-85. doi: 10.1093/ecco-jcc/jjw055. Epub 2016 Feb 29.

    PMID: 26928961BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 8, 2018

Study Start

April 1, 2019

Primary Completion

June 30, 2021

Study Completion

February 28, 2022

Last Updated

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share