RecruitingPhase 4NCT05169593

Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy

Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn Disease


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

292 participants

Start Date

Sep 8, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to preventing Crohn's disease from coming back in the gut after bowel surgery: starting a biologic medication only when endoscopy (a camera procedure) shows early signs of recurrence, versus giving biologics to everyone routinely. The goal is to find the most effective strategy with the least unnecessary treatment. **You may be eligible if...** - You are 18–80 years old with a confirmed diagnosis of Crohn's disease - You have had surgery to remove part of your bowel (ileocolonic resection) within the past 3–40 days - You are at higher-than-average risk of disease coming back after surgery (e.g., due to penetrating disease, previous surgery, active smoking, or recent biologic use) - You have previously tried steroids or immunosuppressants for at least 3 months **You may NOT be eligible if...** - You are not at high risk for post-surgical recurrence - You cannot tolerate the study drug options - You are pregnant or planning to become pregnant - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBiological Drug

Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence


Locations(28)

GZA

Antwerp, Antwerpen, Belgium

UZA

Edegem, Antwerpen, Belgium

Erasmus ziekenhuis

Brussels, Brussels Capital, Belgium

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

UZ Brussel

Jette, Brussels Capital, Belgium

CHwapi

Tournai, Henegouwen, Belgium

ZOL Genk

Genk, Limburg, Belgium

CHC Montlégia

Liège, Liège, Belgium

CHU de Liège

Liège, Liège, Belgium

CHU UCL Namur site Godinne

Yvoir, Namur, Belgium

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Sint lucas Brugge

Bruges, West-Vlaanderen, Belgium

AZ Damiaan

Ostend, West-Vlaanderen, Belgium

OLV Aalst

Aalst, Belgium

Imeldaziekenhuis

Bonheiden, Belgium

AZ Klina

Brasschaat, Belgium

AZ Sint-Jan

Bruges, Belgium

AZ Sint Lucas

Ghent, Belgium

Jessa ziekenhuis

Hasselt, Belgium

AZ Sint Maarten

Mechelen, Belgium

AZ Delta

Roeselare, Belgium

Vitaz

Sint-Niklaas, Belgium

Humanitas research hospital

Milan, Rozzano MI, Italy

IRCCS De Bellis Castellana Grotte

Castellana Grotte, Italy

Careggi University Hospital

Florence, Italy

IRCCS San Raffael Hospital

Milan, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05169593


Related Trials