跳至主要内容
临床试验/NCT07089771
NCT07089771尚未招募不适用

Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy

Region Stockholm1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
480
试验地点
1
主要终点
Proportion of patients with at least one dysplastic lesion detected during surveillance colonoscopy

研究概览

简要总结

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 the colon to highlight abnormal areas (called dye-based chromoendoscopy). The other method uses new technology built into the camera to enhance the view without needing any dye (called virtual chromoendoscopy). Both methods use modern, high-definition equipment.

The purpose of this study is to find out if the newer, dye-free method is as good as the traditional dye method at detecting pre-cancerous changes (called dysplasia) in people with IBD.

Adults with IBD who are due for a routine surveillance colonoscopy may be invited to take part. Participants will be randomly assigned to one of the two methods. No additional procedures are involved, and only the way the colon is viewed differs. The investigators will also look at how long the procedures take, how many biopsies are needed, any complications, and how patients experience the exam. Participants will be followed over time using national health records to check for long-term outcomes.

This research will help doctors better understand which method is most effective and comfortable for patients, and may guide future recommendations for cancer screening in people with IBD.

详细描述

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-free) chromoendoscopy method or a conventional dye-based chromoendoscopy technique. The primary objective is to evaluate whether virtual chromoendoscopy is non-inferior to dye- based chromoendoscopy in detecting dysplasia, a precancerous condition in the colon. Secondary outcomes include the number and type of lesions detected, predictive accuracy of targeted biopsies, examination times, patient-reported experience, complication rates, and biopsy frequency. Eligible participants are adults with a history of extensive colonic IBD of at least eight years, or additional high-risk factors such as primary sclerosing cholangitis or family history of colorectal cancer. Patients with previous colorectal cancer, prior colectomy, known untreated dysplasia, or contraindications to dye application will be excluded. All procedures will be performed using high-definition equipment and standardized bowel preparation protocols. The study includes long-term follow-up through national health registries to evaluate cancer outcomes and subsequent procedures at one and three years post-colonoscopy. The trial will be conducted across several academic and regional centers in Sweden, with an anticipated enrollment of approximately 480 patients to account for potential attrition. This study seeks to inform future guidelines by determining whether a less resource-intensive and potentially more patient-friendly method can provide equivalent surveillance efficacy in this high-risk population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • History of colorectal cancer or prior colectomy
  • Contraindications to dye use
  • Colonoscopies for therapeutic purposes
  • Pregnancy
  • Inability to consent

研究组 & 干预措施

Virtual Chromoendoscopy (VCE) Group

Experimental

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.

干预措施: Virtual Chromoendoscopy (Procedure)

Dye-Based Chromoendoscopy (DCE) Group

Active Comparator

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.

干预措施: Dye-Based Chromoendoscopy (Procedure)

结局指标

主要结局

Proportion of patients with at least one dysplastic lesion detected during surveillance colonoscopy

时间窗: Measured at the time of the index colonoscopy procedure (baseline) and confirmed by histopathological analysis post-procedure (up to 60 days)

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.

次要结局

  • Number of dysplastic lesions detected per 10 minutes of withdrawal time(Measured during the index colonoscopy procedure.)
  • Positive predictive value (PPV) of targeted biopsies(Measured during the index colonoscopy and confirmed by pathology.)
  • Type and characterization of detected lesions(Assessed at the time of index colonoscopy and confirmed by pathology.)
  • Patient experience and satisfaction(Collected within 24-48 hours after the colonoscopy procedure.)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Olga Bednarska

Principal Investigator

Karolinska University Hospital

研究点 (1)

Loading locations...

相似试验