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

Study acronym: SOPRANO-CD
StatusRecruiting
PhasePhase 4
Started2022-09-08
View on ClinicalTrials.gov ↗

Amendment history

2026-04-28
minor
Study Identification, Study Status, Contacts/Locations v9
Study sites28 entries, revised
GZAZAS
Study titlerevised
Prevention of Postoperative Endoscopic Recurrence withWith Endoscopy-driven Versus Systematic Biological Therapy
2024-12-05
minor
Study Identification, Study Status, Contacts/Locations v8
Study sitesdetails revised at 5 of 28 sites
Study titlerevised
Prevention of Postoperative Endoscopic Recurrence Withwith Endoscopy-driven Versus Systematic Biological Therapy
2024-05-07
minor
Study Status, Contacts/Locations v7
Study sites27→28
2024-02-28
minor
Study Status, Contacts/Locations v6
Study sites26→27
2023-05-11
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 2 of 26 sites
Show 4 earlier versions
2023-04-04
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 26 sites
2023-03-16
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 6 of 26 sites
2022-12-21
minor
Study Status, Contacts/Locations v2
Study sitesdetails revised at 7 of 26 sites
2022-11-03
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04→confirmed 2022-09-08
Study sites0→26
2021-12-07
minor
Original filing
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.
Trial Details
NCT Number NCT05169593
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions Crohn Disease
Enrollment 292 participants
Start Date 2022-09-08
Primary Completion 2027-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-05