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Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
Hali
Wadhamini
University of Erlangen-Nürnberg Medical School

Maneno muhimu

Kikemikali

The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho: 12/31/2012
Iliyowasilishwa Kwanza: 02/16/2010
Uandikishaji uliokadiriwa Uliwasilishwa: 02/17/2010
Iliyotumwa Kwanza: 02/18/2010
Sasisho la Mwisho Liliwasilishwa: 01/22/2013
Sasisho la Mwisho Lilichapishwa: 01/23/2013
Tarehe halisi ya kuanza kwa masomo: 01/31/2010
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 12/31/2013
Tarehe ya Kukamilisha Utafiti: 01/31/2014

Hali au ugonjwa

Diarrhea

Uingiliaji / matibabu

Procedure: Group 1: Patients with diarrhea undergoing endoscopy

Procedure: Group 2: Patients with diarrhea undergoing endoscopy.

Awamu

-

Vikundi vya Arm

MkonoUingiliaji / matibabu
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.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 18 Years Kwa 18 Years
Jinsia Inastahiki KujifunzaAll
Njia ya sampuliNon-Probability Sample
Hupokea Wajitolea wa AfyaNdio
Vigezo

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)

Matokeo

Hatua za Matokeo ya Msingi

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]

Hatua za Matokeo ya Sekondari

1. To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea. [February 2012]

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