Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
Raktažodžiai
Santrauka
apibūdinimas
Background:
Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
Scope:
In patients with diarrhea.
Methods:
Patients were randomized in two groups. Group 1: Patients underwent standard video colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure CLE will be performed additionally.
Procedure:
The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
Datos
| Paskutinį kartą patikrinta: | 12/31/2012 |
| Pirmasis pateikimas: | 02/16/2010 |
| Numatytas registravimas pateiktas: | 02/17/2010 |
| Pirmas paskelbtas: | 02/18/2010 |
| Paskutinis atnaujinimas pateiktas: | 01/22/2013 |
| Paskutinis atnaujinimas paskelbtas: | 01/23/2013 |
| Faktinė studijų pradžios data: | 01/31/2010 |
| Numatoma pirminio užbaigimo data: | 12/31/2013 |
| Numatoma studijų užbaigimo data: | 01/31/2014 |
Būklė ar liga
Intervencija / gydymas
Procedure: Group 1: Patients with diarrhea undergoing endoscopy
Procedure: Group 2: Patients with diarrhea undergoing endoscopy.
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Group 1: Patients with diarrhea undergoing endoscopy Standard video colonoscope. | Procedure: Group 1: Patients with diarrhea undergoing endoscopy Patients will undergo colonoscopy for evaluation of their symptoms. |
| Group 2: Patients with diarrhea undergoing endoscopy. Confocal laser endomicroscopy (CLE). | Procedure: Group 2: Patients with diarrhea undergoing endoscopy. Patients will undergo CLE during their endoscopy. Findings will be compared to group 1. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Mėginių ėmimo metodas | Non-Probability Sample |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Written informed consent - Age 18-85 years - Ability of subjects to understand character and individual consequences of clinical trial - Subjects undergoing colonoscopy Exclusion Criteria: - Inability to provide written informed consent - Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s) - Impaired renal function (Creatinine > 1.2 mg/dl) - Pregnancy or breast feeding - Active gastrointestinal bleeding - Known allergy to fluorescein, acriflavin or cresyl violet - Residing in institutions (e.g. prison) |
Rezultatas
Pirminės rezultatų priemonės
1. To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy. [February 2012]
Antrinės rezultatų priemonės
1. To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea. [February 2012]
