Assessing the Histological Quality of Biopsy Samples Obtained With Multibite Forceps

NCT05227079 | Completed

• 1 other identifier: DMED-2634-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection; Celiac Disease

Keywords

Biopsy; Histological quality; Endoscopy; Forceps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time duration

  Duration of endoscopy

Study Arms (2)

Group A (double bite forceps)

ACTIVE COMPARATOR

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

Group B (multiple bite forceps)

EXPERIMENTAL

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

Interventions

MultCROC multibite forcep DEVICE

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

Group B (multiple bite forceps)

Conventional double bite forcep DEVICE

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

Group A (double bite forceps)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lawrence Charles Hookey: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (5)

• 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.

  PMID: 21601201 BACKGROUND

• 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.

  PMID: 17087937 BACKGROUND

• 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.

  PMID: 23609613 BACKGROUND

• 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.

  PMID: 16996354 BACKGROUND

• 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.

  PMID: 11677476 RESULT

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lawrence C Hookey, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: May 1, 2022
• Primary Completion: December 21, 2022
• Study Completion: July 30, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)