Assessing the Histological Quality of Biopsy Samples Obtained With Multibite Forceps

NCT ID: NCT05227079

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-07-30

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.

Conditions

Helicobacter Pylori Infection; Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional double bite forcep

Intervention Type: DEVICE

Use of conventional double bite forceps that can store up to two specimens in one pass through endoscope

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.

Group Type: EXPERIMENTAL

MultCROC multibite forcep

Intervention Type: DEVICE

Alligator style 2.4 mm diameter jaws that can hold up to six samples in one pass through endoscope.

Interventions

MultCROC multibite forcep

Alligator style 2.4 mm diameter jaws that can hold up to six samples in one pass through endoscope.

Intervention Type: DEVICE

Conventional double bite forcep

Use of conventional double bite forceps that can store up to two specimens in one pass through endoscope

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lawrence Charles Hookey

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Charles Hookey

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lawrence C Hookey, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 21601201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17087937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23609613 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16996354 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11677476 (View on PubMed)

Other Identifiers

DMED-2634-21

Identifier Type: -

Identifier Source: org_study_id