Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03222011

Acronym

STRIDENT

Enrollment

Registered

2017-07-19

Start date

2017-10-09

Completion date

2021-02-28

Last updated

2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel

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 and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.

Interventions

PROCEDUREStandard (single) endoscopic stricture dilatation

single endoscopic stricture dilatation

PROCEDUREIntensive endoscopic stricture dilatation

3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

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

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 using the Obstructive Symptom Score (OSS).	6 months	The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (no pain, mild, moderate, severe, unbearable)

Secondary

Measure	Time frame	Description
Improvement in imaging parameters	6 months	MRI and intestinal ultrasound
Improvement in endoscopic features	6 months	Increased patency of strictures on endoscopy
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).	3, 6 and 12 months	The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (no pain, mild, moderate, severe, unbearable)
Improvement in patient reported outcomes (PROs)	6 months	IBDQ
Technical success of procedure	At time of procedure	Successful endoscopic procedure
Avoidance of surgery	6 months	Requirement for surgical resection of stricture

Countries

Australia

Contacts

Primary ContactJulien Schulberg, MBBS

stridentstudy@svha.org.au+61 3 92312211

Backup ContactAmy Hamilton, PhD