Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
Conditions
Keywords
Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture
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.
Interventions
Standard dose adalimumab induction and maintenance
DRUGThiopurine
Dose optimized thiopurine
PROCEDUREEndoscopic balloon dilatation
Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.
Sponsors
Australasian Gastro Intestinal Research Foundation
AbbVie
St Vincent's Hospital Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label study
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in obstructive symptoms. | 12 months | Improved pain and or frequency of pain compared to baseline. Obstructive symptoms determined by prospective diary documenting number of episodes of pain in previous 2 weeks and severity of the pain episodes using four-level Likert scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in symptoms | 4, 8 and 12 months | Improved pain and or frequency of pain compared to baseline. Obstructive symptoms determined by prospective diary documenting number of episodes of pain in previous 2 weeks and severity of the pain episodes using four-level Likert scale. |
| Improvement in biochemical inflammatory parameters | 12 months | Serum CRP and fecal calprotectin |
| Improvement in imaging parameters (Intestinal ultrasound) | 12 months | Limberg's score |
| Surgery | 12 months | The number of patients that require surgical resection of stricture due to failure of drug therapy. |
| Improvement in patient reported outcomes (PROs) | 12 months | SF36 |
| Improvement in imaging parameters | 12 months | Modified MaRIA score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure | 12 months | Number of patients who drop out of the study because of clinical symptoms, acute bowel obstruction, unscheduled endoscopic or surgical intervention. |
Countries
Australia
Outcome results
None listed