Clinical trial NCT03220841: Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Official title: Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn Disease
Inflammatory Bowel Diseases
Stricture; Bowel
Keywords: Crohn Disease
Inflammatory Bowel Disease
Intestinal stricture
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
Collaborators: name: Australasian Gastro Intestinal Research Foundation
name: AbbVie
First posted: 2017-07-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Detailed description: Prospective randomised controlled study. Patients with Crohn's Disease who have symptomatic inflammatory intestinal strictures will be randomised to receive standard drug therapy (Anti-TNF monotherapy at standard dose) or intensive drug therapy (Intense Anti-TNF dose induction and escalation for continued inflammation in combination with thiopurine) for 12 months.

Eligibility criteria: Inclusion Criteria:

* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

Exclusion Criteria:

* Acute bowel obstruction requiring urgent surgical intervention
* Deemed by treating physician to have high risk of acute bowel obstruction
* Concurrent active perianal sepsis
* Internal fistulising disease in association with strictures (entero-enteric stulas)
* Low rectal or anal strictures
* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
* Inability to give informed consent
* Suspected perforation of the gastrointestinal tract
* Pregnancy
* Inability to undergo MRI small bowel due to a contraindication.

Primary outcomes:
measure: Improvement in obstructive symptoms.
timeFrame: 12 months
Secondary outcomes:
measure: Improvement in symptoms
timeFrame: 4, 8 and 12 months
measure: Improvement in biochemical inflammatory parameters
timeFrame: 12 months
measure: Improvement in imaging parameters (Intestinal ultrasound)
timeFrame: 12 months
measure: Improvement in imaging parameters
timeFrame: 12 months
measure: Surgery
timeFrame: 12 months
measure: Improvement in patient reported outcomes (PROs)
timeFrame: 12 months
measure: Improvement in patient reported outcomes (PROs)
timeFrame: 12 months
Other outcomes:
measure: Treatment Failure
timeFrame: 12 months
Locations:
city: Melbourne
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
Study officials:
affiliation: St Vincent's Hospital Melbourne
name: Emily Wright, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital Melbourne
name: Bronte Holt, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital Melbourne
name: Michael Kamm, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schulberg JD, Wright EK, Holt BA, Hamilton AL, Sutherland TR, Ross AL, Vogrin S, Miller AM, Connell WC, Lust M, Ding NS, Moore GT, Bell SJ, Shelton E, Christensen B, De Cruz P, Rong YJ, Kamm MA. Intensive drug therapy versus standard drug therapy for symptomatic intestinal Crohn's disease strictures (STRIDENT): an open-label, single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):318-331. doi: 10.1016/S2468-1253(21)00393-9. Epub 2021 Dec 8.