NCT03861689: PLACE-PCD

Tight Control Management in Perianal Crohn's Disease

Status unknown NA Last updated 18 January 2022

What this trial tests

NA trial testing MRI pelvis in Inflammatory Bowel Diseases in 40 participants. Status unknown.

Timeline

1 July 2019

Primary endpoint
12 January 2022

30 June 2024

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 July 2019
Primary completion	12 January 2022
Estimated completion	30 June 2024
Sites	1 location across Hong Kong

Drugs / interventions tested

• MRI pelvis

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Perianal Fistula — all drugs for Perianal Fistula →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Inflammatory Bowel Diseases or Perianal Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Perianal Crohn's disease (pCD) affects around one-third of patients with Crohn's disease (CD) during their disease course. It represents a distinct disease phenotype and causes significant morbidity, often requiring multiple surgical interventions. However, treatment of pCD is still challenging and unsatisfactory. Only approximately one-third of pCD patients responded to biologic treatment. Overall, medical therapy with anti-TNF could only achieve prolonged remission in 30-40% of pCD cases. At the same time, surgical treatment could only lead to a favourable outcome in around 50% of patients with a higher recurrence rate in patients with complex than in simple fistulae. Recently, combination of optimal medical therapy with surgical therapy (drainage of sepsis and insertion of seton), with radiological guidance, has been suggested as the standard management so as to improve the outcomes of complex pCD.

Magnetic resonance imaging (MRI) is considered to be the gold standard imaging technique for perianal CD. It can visualise the anal sphincter and the pelvic floor muscles, as well as the fistula tracts and abscesses. Previous studies using MRI to monitor treatment response to anti-TNF revealed that radiological healing lagged behind clinical remission by a median of 12 months and that long-term maintenance therapy is probably required to prevent recurrence despite a clinically healed external opening. Therefore, we hypothesize that serial monitoring with MRI is important.

Recently, there has been some advance in the surgical treatment of perianal Crohn's disease. FiLaCTM uses a radial-emitting disposable laser fibre for endofistular therapy. Recent systemic review and meta-analysis showed that the primary success rate was 73.3% (11/15) in patients with perianal Crohn's fistula.

There has been breakthrough in the management of luminal Crohn's disease. The CALM study has showed that timely escalation of anti-TNF on the basis of clinical symptoms combined with biomarkers in patients with luminal Crohn's disease resulted in better clinical and endoscopic outcomes than symptom-driven decision alone. It is unsure whether this approach is also applicable to patients with perianal Crohn's disease.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.