Actively Recruiting
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
292
Participants Needed
28
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
With this prospective, randomized, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited. Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.
CONDITIONS
Official Title
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening
- Diagnosed with Crohn's disease by radiology, endoscopy, or histology
- Male or female aged 18 to 80 years
- Underwent ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 to 40 days before screening, or if temporary ileostomy, resection within 8 months and restoration of fecal stream within 3 to 40 days before screening
- Increased risk for postoperative recurrence due to penetrating disease, previous ileocolonic resection within 10 years, two or more previous ileocolonic resections, active smoking, or biological therapy within 3 months of surgery
- Curative ileocolonic resection with all inflamed colon removed; small bowel strictureplasties away from anastomosis allowed
- Previous failure of at least 3 months of steroids and/or immunosuppressive therapy, intolerance, or contraindication to these therapies
- Able and willing to start and continue biological therapy as randomized
You will not qualify if you...
- History of primary non-response or secondary loss of response to all five biological therapies (adalimumab, infliximab, ustekinumab, vedolizumab, risankizumab)
- Any condition that may risk participant safety or compliance
- Prior or current treatments jeopardizing safety or trial integrity
- Participation in another interventional trial with investigational drugs or devices
- Starting biological therapy as part of another trial or medical program
- Not understanding Dutch, French, German, or English
- Diagnosis of ulcerative colitis or inflammatory bowel disease type unclassified
- Having ileorectal or ileal pouch-anal anastomosis
- Active perianal disease
- Colorectal stenosis
- Presence of an ostomy
- Sepsis or postoperative complications requiring antibiotics for over 10 days after surgery
- Imminent risk of short bowel syndrome
- Surgery for dysplasia or cancer without ongoing inflammation
- Liver test abnormalities exceeding twice the upper limit, low white blood cells or neutrophils, or low platelets
- Severe kidney, lung, or heart disease
- Ongoing alcohol or substance abuse
AI-Screening
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Trial Site Locations
Total: 28 locations
1
ZAS
Antwerp, Antwerpen, Belgium, 2018
Actively Recruiting
2
UZA
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
3
Erasmus ziekenhuis
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
4
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
5
UZ Brussel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
6
CHwapi
Tournai, Henegouwen, Belgium, 7500
Actively Recruiting
7
ZOL Genk
Genk, Limburg, Belgium, 3600
Actively Recruiting
8
CHC Montlégia
Liège, Liège, Belgium, 4000
Actively Recruiting
9
CHU de Liège
Liège, Liège, Belgium, 4000
Actively Recruiting
10
CHU UCL Namur site Godinne
Yvoir, Namur, Belgium, 5530
Not Yet Recruiting
11
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
12
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
13
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
14
Sint lucas Brugge
Bruges, West-Vlaanderen, Belgium, 8310
Not Yet Recruiting
15
AZ Damiaan
Ostend, West-Vlaanderen, Belgium, 8400
Actively Recruiting
16
OLV Aalst
Aalst, Belgium, 9300
Actively Recruiting
17
Imeldaziekenhuis
Bonheiden, Belgium, 2820
Actively Recruiting
18
AZ Klina
Brasschaat, Belgium, 2930
Actively Recruiting
19
AZ Sint-Jan
Bruges, Belgium, 8000
Actively Recruiting
20
AZ Sint Lucas
Ghent, Belgium, 9000
Actively Recruiting
21
Jessa ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
22
AZ Sint Maarten
Mechelen, Belgium, 2800
Withdrawn
23
AZ Delta
Roeselare, Belgium, 8800
Actively Recruiting
24
Vitaz
Sint-Niklaas, Belgium, 9100
Actively Recruiting
25
Humanitas research hospital
Milan, Rozzano MI, Italy, 20089
Not Yet Recruiting
26
IRCCS De Bellis Castellana Grotte
Castellana Grotte, Italy, 70013
Actively Recruiting
27
Careggi University Hospital
Florence, Italy, 50134
Actively Recruiting
28
IRCCS San Raffael Hospital
Milan, Italy, 20132
Actively Recruiting
Research Team
M
Marc Ferrante, Professor
CONTACT
D
Dorien Beeckmans, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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