IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT07089771 para Doença inflamatória intestinal (DII), Ulcerative Colitis (Disorder), Doença de Crohn, Neoplasmas colorretais está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy 480 Virtual
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07089771 é um estudo intervencionista para Doença inflamatória intestinal (DII), Ulcerative Colitis (Disorder), Doença de Crohn, Neoplasmas colorretais. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de maio de 2026, com o objetivo de incluir 480 participantes. Coordenado por Region Stockholm e deve ser concluído em 31 de dezembro de 2032. Essas informações foram atualizadas no ClinicalTrials.gov em 20 de março de 2026.
Resumo
People with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease affecting the colon, have a higher risk of developing colon cancer over time. To catch early signs of cancer, regular colonoscopies are recommended. In this study, the investigators are comparing two advanced methods of examining the colon during these surveillance colonoscopies. One method uses a special dye sprayed inside th...Mostrar mais
Descrição detalhada
This is a multicenter, prospective, randomized, non-inferiority clinical trial designed to compare the diagnostic performance of two high-definition endoscopic imaging techniques used during surveillance colonoscopy in patients with longstanding inflammatory bowel disease (IBD) who are at increased risk for colorectal cancer. Participants will be randomly assigned to undergo colonoscopy using either a virtual (dye-fr...Mostrar mais
Título oficial
Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy
Condições médicas
Doença inflamatória intestinal (DII)Ulcerative Colitis (Disorder)Doença de CrohnNeoplasmas colorretaisOutros IDs do estudo
- 2025-02302-01
Número NCT
Data de início (real)
2026-05-01
Última atualização postada
2026-03-20
Data de conclusão (estimada)
2032-12-31
Inscrição (estimada)
480
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
virtual chromoendoscopy
dye-based chromoendoscopy
dysplasia detection
IBD surveillance colonoscopy
dye-based chromoendoscopy
dysplasia detection
IBD surveillance colonoscopy
Propósito principal
Diagnóstico
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalVirtual Chromoendoscopy (VCE) Group Participants randomized to this arm will undergo surveillance colonoscopy using high-definition virtual chromoendoscopy. This technique enhances mucosal visualization through advanced imaging technology without the use of dyes. The colonoscope's built-in virtual chromoendoscopy mode will be used to detect and characterize dysplastic lesions during withdrawal. | Virtual Chromoendoscopy High-Definition Virtual Chromoendoscopy (HD-VCE):
Surveillance colonoscopy using high-definition virtual chromoendoscopy enhances mucosal visualization through advanced imaging filters integrated into the colonoscope. This dye-free technique improves detection of dysplasia by increasing contrast and highlighting subtle mucosal patterns during withdrawal. HD-VCE reduces procedure time and eliminates risks related to ...Mostrar mais |
Comparador ativoDye-Based Chromoendoscopy (DCE) Group Participants randomized to this arm will undergo surveillance colonoscopy using high-definition dye-based chromoendoscopy. Indigo carmine dye will be sprayed segmentally on the colonic mucosa via a dye spray catheter to enhance visualization of mucosal patterns and detect dysplasia. Targeted biopsies will be taken from suspicious areas identified with dye staining. | Dye-Based Chromoendoscopy High-Definition Dye-Based Chromoendoscopy (HD-DCE):
Surveillance colonoscopy using high-definition dye-based chromoendoscopy involves segmental application of indigo carmine dye via a spray catheter. The dye enhances mucosal surface patterns, aiding dysplasia detection. HD-DCE is currently considered a gold standard in IBD surveillance due to superior dysplasia detection rates. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Proportion of patients with at least one dysplastic lesion detected during surveillance colonoscopy | The primary endpoint is the proportion of enrolled patients in each study arm (HD-VCE and HD-DCE) who have at least one histologically confirmed dysplastic lesion (including low-grade dysplasia, high-grade dysplasia, or colorectal cancer) detected during the index surveillance colonoscopy. | Measured at the time of the index colonoscopy procedure (baseline) and confirmed by histopathological analysis post-procedure (up to 60 days) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Number of dysplastic lesions detected per 10 minutes of withdrawal time | The rate of dysplastic lesions detected normalized by the colonoscope withdrawal time (number of dysplasia findings per 10 minutes) during the surveillance colonoscopy. | Measured during the index colonoscopy procedure. |
Positive predictive value (PPV) of targeted biopsies | The proportion of biopsies taken from suspicious lesions that are confirmed histologically as dysplastic or neoplastic. | Measured during the index colonoscopy and confirmed by pathology. |
Type and characterization of detected lesions | Classification and histopathological characterization of lesions detected, including cancer, adenomas with low- or high-grade dysplasia, sessile serrated lesions (with or without dysplasia), hyperplastic polyps, inflammatory or post-inflammatory polyps, and non-dysplastic lesions. | Assessed at the time of index colonoscopy and confirmed by pathology. |
Patient experience and satisfaction | Self-reported patient experience and satisfaction scores collected using the validated survey Patient Experience Colonoscopy Scale (PECS), evaluating comfort and acceptability of each colonoscopy method. Survey responses are rated on a 4-point Likert scale ranging from very poor agreement to very good agreement, with higher values representing better outcomes. | Collected within 24-48 hours after the colonoscopy procedure. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Age ≥ 18 years and one of the criteria beneath:
- Extensive ulcerative colitis or indeterminate colitis (IBD-U), or Crohn's colitis involving at least one-third of the colon, with a disease history of at least 8 years
- IBD or IBD-U with primary sclerosing cholangitis (PSC)
- IBD or IBD-U with a family history of colorectal cancer in a first-degree relative
- History of colorectal cancer or prior colectomy
- Contraindications to dye use
- Colonoscopies for therapeutic purposes
- Pregnancy
- Inability to consent
Region StockholmResponsável pelo estudo
Olga Bednarska, Investigador principal, Principal Investigator, Karolinska University Hospital
Contato central do estudo
Contato: Olga Bednarska, MD PhD, 0046703980931, [email protected]
1 Locais do estudo em 1 países
Karolinska University Hospital, Stockholm, 141 57, Sweden
Olga Bednarska, MD PhD, Contato, 0046703980931, [email protected]