Tight Control Management in Perianal Crohn's Disease

NCT03861689 | Unknown DMC

• 1 other identifier: PLACE-PCD_Protocol_20200909 v6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Perianal Fistula

Keywords

Perianal Crohn's disease; MRI

Outcome Measures

Primary Outcomes (1)

• Change in the disease activity in patients with perianal Crohn's disease

  Change in the proportion of patients with perianal Crohn's disease achieving clinical remission under tight monitoring using MRI guidance compared to standard care

  24 months

Secondary Outcomes (4)

• Number of pCD patients achieving closure of external fistula opening with FiLAC

  24 months

• Proportion of pCD patients requiring proctectomy, defunctioning surgery

  24 months

• Number of surgeries required for perianal Crohn's disease

  24 months

• Side effects profile

  24 months

Other Outcomes (1)

• Number of patients with adverse events associated with FiLAC treatment

  24 months

Study Arms (2)

Tight control arm

ACTIVE COMPARATOR

Patients in the tight control arm will have additional FiLAC treatment within 24 months if the anatomy of the fistula is favourable. MRI pelvis will be performed at baseline and every 6 months. Biologic dosage will be adjusted according to MRI pelvis findings.

Diagnostic Test: MRI pelvis

Control arm

NO INTERVENTION

Patients in the control arm will have management according to physician own decision.

Interventions

MRI pelvis DIAGNOSTIC_TEST

MRI pelvis monitoring every 6 months; FiLAC to treat fistula tract within 24 months if the anatomy of the fistula is favourable

Also known as: FiLAC

Tight control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Confirmed diagnosis of perianal Crohn's disease
• On biologics or will start biologics

You may not qualify if:

• Patients who have perianal fistula due to causes other than Crohn's disease
• Patients who have allergic reaction / contraindications to anti-TNF
• Patients who have active cancer
• Patients who have contraindications for MRI
• Known pregnancy
• For patients who refuse to participate in the tight monitoring arm, they will be consented and recruited to the control arm for comparison.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (33)

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MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Wing Yan Mak, MRCP

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 4, 2019
• Study Start: July 1, 2019
• Primary Completion: January 12, 2022
• Study Completion: June 30, 2024
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)