Assessing the Histological Quality of Biopsy Samples Obtained With Multibite Forceps

Comparison of the Histological Quality of Endoscopic Biopsy Samples Obtained With Novel Multiple-bite Forceps Versus Conventional Double Bite Forceps

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.

Study Overview

• Status: Completed
• Conditions: Celiac Disease; Helicobacter Pylori Infection
• Intervention / Treatment: Device: Conventional double bite forcep; Device: MultCROC multibite forcep

Detailed Description

This will be a prospective randomized noninferiority study that will take place at Hotel Dieu Hospital. Based on a statistical power calculation, a total of 100 patients are required for enrollment. Enrollment will take place at the outpatient endoscopy suite at Hotel Dieu Hospital. Patients will be reviewed for eligibility as per the inclusion and exclusion criteria and those deemed eligible will consent for participation. Members of the research time will attempt to contact patients two to three weeks prior to their schedule endoscopy for consent. If unable to reach them after two attempts, they will then be consented for their participation during the day of their endoscopy at Hotel Dieu Hospital. Once enrolled in the study, each patient will be randomly allocated to one of two groups (group A and group B) using a computer randomizer generator. The aim is to have equal numbers in both groups (ie. 50 patients in each group). Participants in group A will have their biopsies during endoscopy taken with the conventional double bite forceps. On the other hand, participants in group B will have their biopsies taken with the multiple bite forceps. Each patient in both groups will have at least six biopsies taken. In both groups, biopsies will be taken for assessment of H. pylori and/or celiac disease. Patients recruited will be those who would require these biopsies to be taken regardless of this study. The samples will be sent to pathology where two independent expert gastrointestinal pathologists will examine the slides and grade each specimen using a five-point scale. The overall histological score given to samples will then be assessed to compare those retrieved with the multiple bite forceps and conventional forceps.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lawrence Hookey, MD; Phone Number: 2292 6135443400; Email: lawrence.hookey@kingstonhsc.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5G2
      • Hôtel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who were referred for outpatient upper endoscopy at Hotel Dieu Hospital requiring biopsies to investigate for celiac disease or H. Pylori infection.

Exclusion Criteria:

• Patients with clinical or endoscopic evidence of gastric mucosal atrophy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (double bite forceps); 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.	Device: Conventional double bite forcep; Use of conventional double bite forceps that can store up to two specimens in one pass through endoscope
Experimental: Group B (multiple bite forceps); 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.	Device: MultCROC multibite forcep; Alligator style 2.4 mm diameter jaws that can hold up to six samples in one pass through endoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time duration	Total time taken to retrieve six biopsies with the multiple bite forceps compared to time taken to retrieve six biopsies using double bite forceps	Duration of endoscopy

Collaborators and Investigators

• Sponsor: Lawrence Charles Hookey
• Investigators: Principal Investigator: Lawrence C Hookey, MD, Queen's University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Biopsy; Endoscopy; Histological quality; Forceps
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: DMED-2634-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No