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Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease

6 lipca 2026 zaktualizowane przez: Xiaolei Wang, Shanghai 10th People's Hospital
This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD). It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery. The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat. Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent. Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study is a retrospective cohort study aiming to compare the efficacy of different biologics in preventing endoscopic recurrence after surgery for Crohn's disease (CD). It plans to include 198 adult CD patients who underwent intestinal resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into an anti-TNF group (e.g., infliximab, adalimumab) and a non-anti-TNF group (e.g., vedolizumab, ustekinumab) based on the biologic agent used within six weeks post-surgery. The primary outcome is the rate of endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include the rate of severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and pathological changes in the intestinal tissue and mesenteric fat. Subgroup analyses will be conducted to explore differences in efficacy across varying levels of recurrence risk and resection extent. Through retrospective data collection and statistical analyses including multivariate regression and survival analysis, this study aims to provide real-world evidence to optimize the selection of postoperative biologic therapy in clinical practice.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

198

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

This retrospective cohort study will include adult patients with Crohn's disease who underwent CD-related intestinal resection at Shanghai Tenth People's Hospital between January 1, 2015 and April 1, 2025. Eligible patients initiated postoperative prophylactic biologic therapy within 6 weeks after surgery and had available postoperative follow-up data, including endoscopic assessment within 6 to 12 months after surgery or other clinical data for recurrence evaluation. Patients will be grouped according to the type of postoperative prophylactic biologic therapy, including anti-TNF biologics and non-anti-TNF biologics.

Opis

Inclusion Criteria:

  • Age ≥18 years.
  • Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings.
  • Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection.
  • Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery.
  • Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months.
  • Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence.

Exclusion Criteria:

  • Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy.
  • Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy.
  • No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment.
  • Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate.
  • Other conditions considered by the investigators to be inappropriate for inclusion.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Postoperative anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic anti-TNF biologic therapy within 6 weeks after surgery, including infliximab or adalimumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
Biologiczny: Infliximab
Infliximab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 5 mg/kg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.
Biologiczny: Adalimumab
Adalimumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 160 mg subcutaneously at week 0, 80 mg at week 2, and 40 mg every 2 weeks from week 4 onward.
Postoperative non-anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic non-anti-TNF biologic therapy within 6 weeks after surgery, including vedolizumab or ustekinumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
Biologiczny: Vedolizumab
Vedolizumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 300 mg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.
Biologiczny: Ustekinumab (UST)
Ustekinumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen included a weight-based intravenous induction dose, followed by 90 mg subcutaneously every 8 weeks.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Endoscopic recurrence rate
Ramy czasowe: 6 to 12 months after surgery
The proportion of patients with endoscopic recurrence, defined as a Rutgeerts score ≥ i2 on ileocolonoscopy performed 6 to 12 months after CD-related intestinal resection.
6 to 12 months after surgery

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Severe endoscopic recurrence rate
Ramy czasowe: 6 to 12 months after surgery
The proportion of patients with severe endoscopic recurrence, defined as a Rutgeerts score ≥ i3 on postoperative ileocolonoscopy.
6 to 12 months after surgery
Clinical recurrence rate
Ramy czasowe: Up to 5 years after surgery
The proportion of patients with clinical recurrence, defined as worsening Crohn's disease-related symptoms supported by endoscopic, radiologic, ultrasonographic, laboratory, or medical record evidence, or requiring treatment escalation, hospitalization, or reoperation due to Crohn's disease activity.
Up to 5 years after surgery
Long-term endoscopic recurrence rate
Ramy czasowe: 3 and 5 years after surgery
The proportion of patients with endoscopic recurrence during long-term follow-up, defined as a Rutgeerts score ≥ i2 on follow-up endoscopy.
3 and 5 years after surgery
Crohn's disease-related rehospitalization rate
Ramy czasowe: Up to 5 years after surgery
The proportion of patients requiring rehospitalization due to Crohn's disease activity, complications, or treatment-related problems during follow-up.
Up to 5 years after surgery
Crohn's disease-related reoperation rate
Ramy czasowe: Up to 5 years after surgery
The proportion of patients requiring repeat abdominal surgery due to Crohn's disease recurrence or related complications during follow-up.
Up to 5 years after surgery
Drug persistence
Ramy czasowe: Up to 5 years after treatment initiation
Time from initiation of postoperative prophylactic biologic therapy to treatment discontinuation, switch to another biologic or immunomodulator, or discontinuation due to intolerance or adverse events.
Up to 5 years after treatment initiation

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Shanghai 10th People's Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 stycznia 2026

Zakończenie podstawowe (Szacowany)

30 września 2026

Ukończenie studiów (Szacowany)

31 października 2026

Daty rejestracji na studia

Pierwszy przesłany

6 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 lipca 2026

Pierwszy wysłany (Rzeczywisty)

10 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SHSY-IEC-6.0/26K14/P01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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