Establishment of surveillance system for the longstanding ulcerative colitis patients Comparative study of efficacy for the targeted biopsy and the step biopsy

UMIN ID: UMIN000001608

Registered date:05/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 2009/01/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Targeted biopsy
Step biopsy

Outcome(s)

• Primary Outcome: The number of neoplastic lesions detected during surveillance colonoscopy
• Secondary Outcome: The detection rate of neoplastic lesions, examination time and a number of biopsies in the surveillance colonoscopy (economical efficiency, incidence rate of complication that requires the special treatment, risk factor of neoplasia)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients who have past history of colon cancer and/or ulcerative colitis associated neoplasm 2) Patients suspected of bleeding diathesis or coagulation abnormality 3) Renal dysfunction (Cre > 1.2 mg/dl) 4)Pregnancy or breast feeding 5)Otherwise, patiesnts who investigator judged ineligible to register

Related Information

• Primary Sponsor: Teikyo University School of Medicine
• Source(s) of Monetary Support: Research Committee of IBD by The Ministry of Health and Welfare, JSCCR (Japanese society for cancer of the colon and rectum)