Post-Operative Crohn's Disease Outcome in Children

NCT03681652 | Recruiting

• 1 other identifier: POPCORN
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To examine the effect of prophylaxis therapy on clinical and endoscopic disease recurrence in children with Crohn's Disease (CD) following ileo-cecal resection. Hypothesis: Post-operative pediatric patients treated with anti-Tumor necrosis factor (TNF) prophylaxis will demonstrate lower endoscopic recurrence rates at 1 year and lower clinical recurrence rates at 2 years compared with thiopurines treated patients. Design: A multi-center, prospective, observational study. Patients with either thiopurines or anti-TNF prophylaxis will be enrolled 0-6 months following ileo-cecal resection. Prophylactic treatment will be decided at the discretion of the treating physician and not as a part of the study. According to standard-of-care, patients will undergo a colonoscopic evaluation 6-9 month following surgery. Study visits will be performed at 6 months following resection, 12 months, 18 months and 24 months. Setting: Porto group and IBD interest group pediatric gastroenterology centers. Participants: Children 6 year to 18 years (Overall, 84 patients) with CD following limited ileo-cecal resection. Main outcome measure: 1. Endoscopic recurrence at 1 year (according to Rutgeerts Score: i2-i4). 2. Clinical recurrence at 2 years (according to pediatric Crohn's disease activity index-PCDAI: ≥10). Secondary outcome measures: 1. Re-operation rate at 2 years. 2. Exacerbation-free quartiles at 2 years. 3. Anthropometric and laboratory measures including calprotectin at each visit. 4. Changes in fecal microbiome- baseline, 1 year and 2 years. Inclusion criteria: 1. CD with phenotypes L1 and L3 following ileo-cecal resection. 2. No active perianal disease. 3. Prophylactic therapy with either thiopurines or anti-TNF. Exclusion criteria: 1. Pregnancy. 2. Active perianal disease (draining fistula or abscess). 3. Post-operative intra-abdominal complication (fistula or abscess). Sample size: In order to demonstrate 20% difference in endoscopic recurrence rate between groups is significant, we will need to study 42 children in each group to be able to reject the null hypothesis that the failure rates between the groups are equal with probability (power) of 80% and a type I error probability of 0.05.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Endoscopic recurrence (Rutgeerts score ≥ i2b)

  According to Rutgeerts score The Rutgeerts score: i0-no lesions in the neoterminal ileum i1-fewer than 5 aphthous lesions in the neoterminal ileum i2a-lesions confined to the ileocolonic anastomosis, including anastomotic stenosis), i2b-more than 5 aphthous ulcers or larger lesions, with normal mucosa in between, in the neoterminal ileum, with or without anastomotic lesions i3-diffuse aphthous ileitis with diffusely inflamed mucosa i4-large ulcers with diffuse mucosal inflammation or nodules or stenosis in the neoterminal ileum.

  12 months following resection

Secondary Outcomes (3)

• Clinical recurrence according to PCDAI: ≥10

  24 months

• Re-operation rate

  24 months

• Exacerbation free quartiles

  24 months

Study Arms (2)

Azathioprine or 6MP

Patients treated with thiopurines for post-operative prophylaxis.

Drug: Azathioprine

Anti-TNF drug

Patients treated with anti-TNF alpha monotherapy for post-operative prophylaxis.

Drug: Anti-TNF Drug

Interventions

Azathioprine DRUG

Children with Crohn's disease who are treated with azathioprine for post-operative prophylaxis following ileo-cecal resection

Also known as: Imuran

Azathioprine or 6MP

Anti-TNF Drug DRUG

Children with Crohn's disease who are treated with anti-TNF monotherapy for post-operative prophylaxis following ileo-cecal resection

Also known as: Remicade, Remsima, Humira

Anti-TNF drug

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children at age 6 year to 17 years diagnosed with CD following first ileo-cecal resection.

You may qualify if:

• Crohn's disease
• Age: 6 - 17 years (inclusive)
• L1 or L3 phenotypes
• Ileocecal resection in the previous 3 months
• No active perianal disease (including draining fistula or a peri-anal abscess)
• Prophylactic therapy with either thiopurines or anti-TNF has been initiated

You may not qualify if:

• Pregnancy
• Renal Failure
• Current abscess or perforation of the bowel
• Post-operative intra-abdominal complication (fistula or abscess)
• Previous malignancy
• Sepsis or active bacterial infection
• IBD unclassified

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schneider Children's Hospital

Petah Tikva, Israel, 4920235, Israel

RECRUITING

Related Publications (2)

• De Cruz P, Kamm MA, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Jakobovits S, Florin TH, Gibson PR, Debinski H, Gearry RB, Macrae FA, Leong RW, Kronborg I, Radford-Smith G, Selby W, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Desmond PV. Efficacy of thiopurines and adalimumab in preventing Crohn's disease recurrence in high-risk patients - a POCER study analysis. Aliment Pharmacol Ther. 2015 Oct;42(7):867-79. doi: 10.1111/apt.13353. Epub 2015 Aug 28.

  PMID: 26314275 BACKGROUND

• Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6.

  PMID: 2394349 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Azathioprine; Infliximab; CT-P13; Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Amit Assa, MD

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Assa, MD

CONTACT

+972543522211; dr.amit.assa@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IBD program

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: February 11, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 15, 2025

Record last verified: 2024-11

Locations

IL (1)