Rectal forceps biopsy procedure in cystic fibrosis: technical aspects and patients perspective for clinical trials feasibility

Autor: Luciana Rodrigues de Meirelles, Marisa Sousa, Antonio Fernando Ribeiro, Margarida D. Amaral, Silvia Regina Cardoso, Karl Kunzelmann, Rita Barbosa de Carvalho, Maria de Fátima Servidoni, José Dirceu Ribeiro, Maria Alice Rosa Ribeiro, Adriana Mendes Vinagre
Rok vydání: 2012
Předmět:
Glycerol
Cystic Fibrosis
Biopsy
Rectal biopsy
Cystic Fibrosis Transmembrane Conductance Regulator
Fluorescent Antibody Technique
Sodium Chloride
Cystic fibrosis
0302 clinical medicine
Surveys and Questionnaires
Mannitol
Child
Forceps biopsy
0303 health sciences
Cathartics
Gastroenterology
General Medicine
Prognosis
Surgical Instruments
3. Good health
Patient comfort
Patient Satisfaction
medicine.symptom
Anesthetics
Intravenous
Research Article
Adult
Forceps
medicine.medical_specialty
Sedation
Blotting
Western
Cathartic
Pain
03 medical and health sciences
Patient satisfaction
Internal medicine
medicine
Humans
030304 developmental biology
business.industry
Rectum
Quality control
Hepatology
medicine.disease
Surgery
Clinical trial
030228 respiratory system
Mutation
Outcome measures clinical trial
business
Zdroj: BMC Gastroenterology
ISSN: 1471-230X
Popis: Background Measurements of CFTR function in rectal biopsies ex vivo have been used for diagnosis and prognosis of Cystic Fibrosis (CF) disease. Here, we aimed to evaluate this procedure regarding: i) viability of the rectal specimens obtained by biopsy forceps for ex vivo bioelectrical and biochemical laboratory analyses; and ii) overall assessment (comfort, invasiveness, pain, sedation requirement, etc.) of the rectal forceps biopsy procedure from the patients perspective to assess its feasibility as an outcome measure in clinical trials. Methods We compared three bowel preparation solutions (NaCl 0.9%, glycerol 12%, mannitol), and two biopsy forceps (standard and jumbo) in 580 rectal specimens from 132 individuals (CF and non-CF). Assessment of the overall rectal biopsy procedure (obtained by biopsy forceps) by patients was carried out by telephone surveys to 75 individuals who underwent the sigmoidoscopy procedure. Results Integrity and friability of the tissue specimens correlate with their transepithelial resistance (r = −0.438 and −0.305, respectively) and are influenced by the bowel preparation solution and biopsy forceps used, being NaCl and jumbo forceps the most compatible methods with the electrophysiological analysis. The great majority of the individuals (76%) did not report major discomfort due to the short procedure time (max 15 min) and considered it relatively painless (79%). Importantly, most (88%) accept repeating it at least for one more time and 53% for more than 4 times. Conclusions Obtaining rectal biopsies with a flexible endoscope and jumbo forceps after bowel preparation with NaCl solution is a safe procedure that can be adopted for both adults and children of any age, yielding viable specimens for CFTR bioelectrical/biochemical analyses. The procedure is well tolerated by patients, demonstrating its feasibility as an outcome measure in clinical trials.
Databáze: OpenAIRE
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