Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Phase 4UnknownNCT03220841

St Vincent's Hospital Melbourne78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn Disease Inflammatory Bowel Diseases Stricture; Bowel

Interventions

Adalimumab InjectionDRUG

Standard dose adalimumab induction and maintenance

ThiopurineDRUG

Dose optimized thiopurine

Endoscopic balloon dilatationPROCEDURE

Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Improvement in obstructive symptoms.

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.

Time frame: 12 months

Secondary Outcomes

Improvement in symptoms

Time frame: 4, 8 and 12 months

Improvement in biochemical inflammatory parameters

Serum CRP and fecal calprotectin

Time frame: 12 months

Improvement in imaging parameters (Intestinal ultrasound)

Limberg's score

Time frame: 12 months

Improvement in imaging parameters

Modified MaRIA score

Time frame: 12 months

Surgery

The number of patients that require surgical resection of stricture due to failure of drug therapy.

Time frame: 12 months

Improvement in patient reported outcomes (PROs)

SF36

Time frame: 12 months

Improvement in patient reported outcomes (PROs)

IBDQ

Data from ClinicalTrials.gov

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