NCT01505842

Brief Summary

Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an increased risk of developing cancer. The purpose of this study is to determine if visualizing of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more abnormalities than conventional colonoscopy without dye spray.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

8.2 years

First QC Date

December 29, 2011

Last Update Submit

March 4, 2019

Conditions

Ulcerative ColitisCrohn's Colitis

Keywords

Ulcerative colitisCrohn's diseaseChromoendoscopyDysplasiaNeoplasiaInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of dysplastic lesions

    Number of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy

    12 month

Secondary Outcomes (1)

  • Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia

    12 month

Study Arms (2)

Colonoscopy with chromoendoscopy

EXPERIMENTAL

Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas

Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy

Conventional colonoscopy

ACTIVE COMPARATOR

White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas

Procedure: Conventional white-light colonoscopy

Interventions

Colonoscopy with Indigo-Carmine chromoendoscopyPROCEDURE

Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas

Also known as: Indigo-Carmine
Colonoscopy with chromoendoscopy
Conventional white-light colonoscopyPROCEDURE

White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas

Conventional colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ulcerative colitis or Crohn's colitis satisfying criteria for surveillance colonoscopy:
  • Ulcerative colitis, extensive \> 8 years OR Crohn's colitis involving ≥ 1/3 of colon/rectum
  • history of PSC or
  • history of previous dysplasia on colon biopsies or
  • family history of colon cancer in first degree relative

You may not qualify if:

  • Patients who decline to participate
  • Unable to give informed consent
  • Increased risk of bleeding (i.e. Warfarin, bleeding disorders, Clopidogrel)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karoliniska University Hospital, Dept. of Gastroenterology

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Alexandersson B, Hamad Y, Andreasson A, Rubio CA, Ando Y, Tanaka K, Ichiya T, Rezaie R, Schmidt PT. High-Definition Chromoendoscopy Superior to High-Definition White-Light Endoscopy in Surveillance of Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2101-2107. doi: 10.1016/j.cgh.2020.04.049. Epub 2020 Apr 27.

    PMID: 32353535DERIVED

MeSH Terms

Conditions

Colitis, UlcerativeCrohn DiseaseNeoplasmsInflammatory Bowel Diseases

Interventions

ColonoscopyIndigo Carmine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Peter T Schmidt, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Endoscopy

Study Record Dates

First Submitted

December 29, 2011

First Posted

January 9, 2012

Study Start

February 1, 2011

Primary Completion

April 4, 2019

Study Completion

April 4, 2019

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

SE(1)