Comparison of the Histological Quality of Endoscopic Biopsy Samples Obtained With Novel Multiple-bite Forceps Versus Conventional Double Bite Forceps
Sponsor study identifier
interventional
100
1 country
1
Study Start
May 1, 2022
Actual (reported)Primary Completion
December 21, 2022
Actual (reported)Study Completion
July 30, 2023
Actual (reported)Biopsies are routinely taken during endoscopy and colonoscopy in order to facilitate histological analysis of various disease processes. The current practice of obtaining biopsies involves taking a maximum of two biopsies at a single time (ie. with a single pass). When investigating certain diseases, such as celiac disease, there is a need to obtain several biopsies (sometimes greater than 6) and the current practice of taking one to two biopsies at a time can lengthen endoscopy time. This study investigates a new approved multiple bite forceps that has the ability to retrieve six biopsies during a single pass which could reduce endoscopy time and improve diagnostic yield. This study will assess the histological quality of multiple biopsies when taken with the multiple bite forceps compared to the standard double bite forceps. This multiple bite forcep is approved for clinical use in Canada.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2022
Actual (reported)February 7, 2022
Actual (reported)May 1, 2022
Actual (reported)December 21, 2022
Actual (reported)July 30, 2023
Actual (reported)Histological quality
Comparison of the histological quality of specimens retrieved with multiple bite forceps compared to double bite forceps
Duration of endoscopy and pathological assessment of specimens
Time duration
Duration of endoscopy
Participants in group A will proceed to have their biopsies during endoscopy taken with the conventional double bite forceps. Meaning, they will have two biopsies taken each time the forcep is passed through the endoscope. To obtain a total of six biopsies, the forceps will be passed through the endoscope a total of three times.
Participants in group B will have their biopsies during endoscopy retrieved with the multiple bite forceps. Meaning, they will have six consecutive biopsies taken with each pass through the endoscope.
Alligator style 2.4 mm diameter jaws that can hold up to six samples in one pass through endoscope.
Use of conventional double bite forceps that can store up to two specimens in one pass through endoscope
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
Lebwohl B, Kapel RC, Neugut AI, Green PH, Genta RM. Adherence to biopsy guidelines increases celiac disease diagnosis. Gastrointest Endosc. 2011 Jul;74(1):103-9. doi: 10.1016/j.gie.2011.03.1236. Epub 2011 May 20.
Rostom A, Murray JA, Kagnoff MF. American Gastroenterological Association (AGA) Institute technical review on the diagnosis and management of celiac disease. Gastroenterology. 2006 Dec;131(6):1981-2002. doi: 10.1053/j.gastro.2006.10.004. No abstract available.
Lawrence C Hookey, MD
Queen's University
100 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2022
Clinical Utility of Upper Endoscopy in Diagnosis of Helicobacter Pylori Infection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.
Zaidman JS, Frederick WG, Furth EE, Su CG, Ginsberg GG. Comparison of Pelican single-use multibite biopsy forceps and traditional double-bite forceps: evaluation in a porcine model. Gastrointest Endosc. 2006 Oct;64(4):582-8. doi: 10.1016/j.gie.2006.06.060.
Fantin AC, Neuweiler J, Binek JS, Suter WR, Meyenberger C. Diagnostic quality of biopsy specimens: comparison between a conventional biopsy forceps and multibite forceps. Gastrointest Endosc. 2001 Nov;54(5):600-4. doi: 10.1067/mge.2001.118945.
First Posted
February 7, 2022
Study Start
May 1, 2022
Actual (reported)Primary Completion
December 21, 2022
Actual (reported)Study Completion
July 30, 2023
Actual (reported)Last Updated
April 3, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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