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

BMC Gastroenterology

Research Article

Maria A Ribeiro¹  Adriana M Vinagre²  Maria F Servidoni³  Karl Kunzelmann⁴  Luciana R Meirelles⁵  Rita B de Carvalho⁵  Silvia R Cardoso⁶  Antônio F Ribeiro⁷  José D Ribeiro⁷  Marisa Sousa⁸  Margarida D Amaral⁹ 

[1] CIPED - Research Center in Pediatrics - State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;Faculty of Medical Sciences - State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;Gastrocentro - Endoscopy Unit - State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;Post-graduate Course, Pediatrics Department, State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;Institut für Physiologie - Universität Regensburg, Universitat Strasse 31, D-93053, Regensburg, Germany;Pathological Anatomy Department, University Hospital of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;Post-graduate Course, Pediatrics Department, State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;Endoscopy Unit – University Hospital of Campinas, Campinas, Brazil;Post-graduate Course, Pediatrics Department, State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;Faculty of Medical Sciences - State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;CIPED - Research Center in Pediatrics - State University of Campinas (Unicamp) - Cidade Universitária Zeferino Vaz - Barão Geraldo, SP 13083-872, Campinas, Brazil;University of Lisboa - Faculty of Sciences, BioFIG - Centre for Biodiversity, Functional and Integrative Genomics, 1749-016, Campo Grande, Lisbon, Portugal;Department of Genetics, National Institute of Health – Av, 1649-016, Padre Cruz, Lisbon, Portugal;University of Lisboa - Faculty of Sciences, BioFIG - Centre for Biodiversity, Functional and Integrative Genomics, 1749-016, Campo Grande, Lisbon, Portugal;Department of Genetics, National Institute of Health – Av, 1649-016, Padre Cruz, Lisbon, Portugal;Edifício C8, Departamento de Química e Bioquímica, Faculdade de Ciências da Universidade de Lisboa, 1749-016, Campo Grande, Lisbon, Portugal;

关键词: Quality control;    Patient comfort;    Forceps;    Outcome measures clinical trial;    Rectal biopsy;   

DOI  :  10.1186/1471-230X-13-91

 received in 2012-06-30, accepted in 2013-05-16,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundMeasurements 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.MethodsWe 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.ResultsIntegrity 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.ConclusionsObtaining 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.

【 授权许可】

Unknown   
© Servidoni et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.