Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
Biological Drug: Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
Study summary
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.
Eligibility
Primary outcome measure(s)
- postoperative endoscopic recurrence (Rutgeerts score ≥i2b) — 86 weeks
To compare the postoperative endoscopic recurrence rate in patients with Crohn's disease undergoing an ileocolonic resection with ileocolonic anastomosis randomized to systematic biological therapy or endoscopy-driven biological therapy - need for unscheduled treatment adaptation prior to week 86 — 86 weeks
When, due to clinical symptoms, therapy needs to be started or switched prior to week 86
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| ZAS | Antwerp | Antwerpen | Recruiting |
| UZA | Edegem | Antwerpen | Recruiting |
| Erasmus ziekenhuis | Brussels | Brussels Capital | Recruiting |
| Cliniques Universitaires Saint Luc | Brussels | Brussels Capital | Recruiting |
| UZ Brussel | Jette | Brussels Capital | Recruiting |
| CHwapi | Tournai | Henegouwen | Recruiting |
| ZOL Genk | Genk | Limburg | Recruiting |
| CHC Montlégia | Liège | Liège | Recruiting |
| CHU de Liège | Liège | Liège | Recruiting |
| CHU UCL Namur site Godinne | Yvoir | Namur | Not Yet Recruiting |
| AZ Maria Middelares | Ghent | Oost-Vlaanderen | Recruiting |
| UZ Gent | Ghent | Oost-Vlaanderen | Recruiting |
| UZ Leuven | Leuven | Vlaams-Brabant | Recruiting |
| Sint lucas Brugge | Bruges | West-Vlaanderen | Not Yet Recruiting |
| AZ Damiaan | Ostend | West-Vlaanderen | Recruiting |
| OLV Aalst | Aalst | Belgium | Recruiting |
| Imeldaziekenhuis | Bonheiden | Belgium | Recruiting |
| AZ Klina | Brasschaat | Belgium | Recruiting |
| AZ Sint-Jan | Bruges | Belgium | Recruiting |
| AZ Sint Lucas | Ghent | Belgium | Recruiting |
| Jessa ziekenhuis | Hasselt | Belgium | Recruiting |
| AZ Sint Maarten | Mechelen | Belgium | Withdrawn |
| AZ Delta | Roeselare | Belgium | Recruiting |
| Vitaz | Sint-Niklaas | Belgium | Recruiting |
| Humanitas research hospital | Milan | Rozzano MI | Not Yet Recruiting |
| IRCCS De Bellis Castellana Grotte | Castellana Grotte | Italy | Recruiting |
| Careggi University Hospital | Florence | Italy | Recruiting |
| IRCCS San Raffael Hospital | Milan | Italy | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05169593 on ClinicalTrials.gov ↗ ← All trials in Italy