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Assessing the Histological Quality of Biopsy Samples Obtained With Multibite Forceps

Primary Purpose

Helicobacter Pylori Infection, Celiac Disease

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MultCROC multibite forcep
Conventional double bite forcep
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Helicobacter Pylori Infection focused on measuring Biopsy, Histological quality, Endoscopy, Forceps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (double bite forceps)

Group B (multiple bite forceps)

Arm Description

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.

Outcomes

Primary Outcome Measures

Histological quality
Comparison of the histological quality of specimens retrieved with multiple bite forceps compared to double bite forceps

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2022
Last Updated
April 28, 2023
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT05227079
Brief Title
Assessing the Histological Quality of Biopsy Samples Obtained With Multibite Forceps
Official Title
Comparison of the Histological Quality of Endoscopic Biopsy Samples Obtained With Novel Multiple-bite Forceps Versus Conventional Double Bite Forceps
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Celiac Disease
Keywords
Biopsy, Histological quality, Endoscopy, Forceps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to one of two groups (group A and group B). Group A will include patients who will have their biopsies taken with the conventional double bite forceps during endoscopy. Group B will include patients who will have their biopsies taken with the multiple bite forceps. Each patient in both groups will have the same number of biopsies taken from the same anatomical areas; the only difference will be the number of biopsies that are taken consecutively.
Masking
ParticipantInvestigator
Masking Description
The participant will be blinded as to which forceps (ie. conventional double bite or multiple bite forceps) are used for sampling during endoscopy. The pathologists assessing the histological quality of biopsy specimens will also be blinded to which forceps were used to obtain the samples.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (double bite forceps)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B (multiple bite forceps)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MultCROC multibite forcep
Intervention Description
Alligator style 2.4 mm diameter jaws that can hold up to six samples in one pass through endoscope.
Intervention Type
Device
Intervention Name(s)
Conventional double bite forcep
Intervention Description
Use of conventional double bite forceps that can store up to two specimens in one pass through endoscope
Primary Outcome Measure Information:
Title
Histological quality
Description
Comparison of the histological quality of specimens retrieved with multiple bite forceps compared to double bite forceps
Time Frame
Duration of endoscopy and pathological assessment of specimens
Secondary Outcome Measure Information:
Title
Time duration
Description
Total time taken to retrieve six biopsies with the multiple bite forceps compared to time taken to retrieve six biopsies using double bite forceps
Time Frame
Duration of endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence C Hookey, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21601201
Citation
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.
Results Reference
background
PubMed Identifier
17087937
Citation
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.
Results Reference
background
PubMed Identifier
23609613
Citation
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.
Results Reference
background
PubMed Identifier
16996354
Citation
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.
Results Reference
background
PubMed Identifier
11677476
Citation
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.
Results Reference
result

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Assessing the Histological Quality of Biopsy Samples Obtained With Multibite Forceps

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