Clinical Trial: Confocal Laser Endomicroscopy Findings in Patients With Proctosigmoiditis Before and After Initiation of Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Confocal Laser Endomicroscopy Findings in Patients With Proctosigmoiditis Before and After Initiation of Treatment

Brief Summary:

Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic structures in vivo. The examination is carried out with a confocal laser endomicroscope, which is either part of the endoscope (manufactured by Pentax) or probe based (manufactured by Cellvizio). Hereby, all parts of the gastrointestinal (GI) tract can be examined. The method has potential to replace conventional microscopy and the dynamic nature of the procedure allows visualization of structures and cellular processes in almost real-time. This provides us with a potentially new diagnostic tool with a promising future. To date only a few studies have been published on inflammatory bowel disease (IBD) and in the literature high-quality research is still lacking.

The project consists of a blinded prospective observation and methodology study including inter- and intra-observation of patients with proctitis before and after initiation of local treatment.

Hypothesis: CLE can be used to assess the degree and extend of acute and chronic inflammation and treatment response in patients with ulcerative colitis and is a sensitive supplementary to conventional diagnostics.


Detailed Summary:

Confocal laser endomicroscopy findings in patients with proctosigmoiditis before and after initiation of treatment

Background Inflammatory bowel disease (IBD) includes Crohn's disease and ulcerative colitis. Crohn's disease often strikes the terminal ileum, but may occur from the mouth to the anus. It is characterized by segmental spreading with transmural inflammation and occasional presence of granulomas in the tissue samples. Ulcerative colitis is only found in the colon and involves in practice always the rectum. The inflammation is limited to the mucosa and submucosa, and the diffusion is continuous.

The development of endoscopy has made these procedures a central part of the diagnostic and therapeutic management of patients with gastrointestinal diseases, including IBD. The entire gastrointestinal tract is now available for inspection and therapy. A limitation of these studies is that the histology, which is often essential for the diagnosis and treatment of the patient, cannot always be precisely evaluated by a conventional examination. The proper handling of detected lesions require in addition to the endoscopic evaluation, a histological evaluation of the tissue involved, making tissue samples necessary in order to obtain a definitive diagnosis and thus optimal handling. Therefore, during the endoscopic procedure tissue samples from the intestinal mucosa must be taken, which rarely involves a greater risk to the patient, but causes a delay, due to preparation time for the histological analysis and in some cases even due to re-examination if histopathology is negative. In the treatment of IBD the endoscopic assessment of the severity and extension is absolutely essential for the choice of treatment. The "Gold standard" for the optimal treatment is called "deep" remission, defined by clinical and
Sponsor: Herlev Hospital

Current Primary Outcome:

  • CLE findings are recorded and compared with the findings of conventional colonoscopy (Mayo score), including observations for the control group [ Time Frame: The trial will go on for 2 years ]
  • CLE and colonoscopy findings are compared with the pathological evaluation of tissue samples. [ Time Frame: The trial will go on for 2 years ]
  • Intra-and inter-observer agreement between 3 CLE operators is calculated by kappa statistics [ Time Frame: The trial will go on for 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of therapy with topical therapy, based on the results of the conventional colonoscopy and CLE [ Time Frame: The trial will go on for 2 years ]
    A determination of the relationship between CLE findings (the parameters described in the protocol and validated in the inter- and intra-observer study) and conventional colonoscopy findings (Mayo-score) with the treatment effect for the individual patient is conducted. To evaluate the treatment effect the Wilcoxon Signed Rank test is used.
  • Registering time of the procedure. [ Time Frame: The trial will go on for 2 years ]
  • Registering possible complications [ Time Frame: The trial will go on for 2 years ]
    Registering possible complications meaning intestinal perforations and bleeding


Original Secondary Outcome:

  • Effect of therapy with topical therapy, based on the results of the conventional colonoscopy and CLE [ Time Frame: The trial will go on for 2 years ]
  • Registering time of the procedure. [ Time Frame: The trial will go on for 2 years ]
  • Registering possible complications [ Time Frame: The trial will go on for 2 years ]


Information By: Herlev Hospital

Dates:
Date Received: September 6, 2012
Date Started: October 2012
Date Completion:
Last Updated: August 16, 2016
Last Verified: August 2016