## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** DMED-2634-21
#### Organization
**Class:** OTHER
**Full Name:** Queen's University
### Status Module
#### Completion Date
**Date:** 2023-07-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-12-21

**Type:** ACTUAL

#### Start Date
**Date:** 2022-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2022-02-07
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-27
**Study First Submit QC Date:** 2022-01-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lawrence Charles Hookey

#### Responsible Party

**Investigator Affiliation:** Queen's University

**Investigator Full Name:** Lawrence Charles Hookey

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Helicobacter Pylori Infection

- Celiac Disease

**Keywords:**

- Biopsy

- Histological quality

- Endoscopy

- Forceps

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** DOUBLE

**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.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: Conventional double bite forcep

**Label:** Group A (double bite forceps)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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 Names:**

- Device: MultCROC multibite forcep

**Label:** Group B (multiple bite forceps)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group B (multiple bite forceps)

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

**Name:** MultCROC multibite forcep

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Group A (double bite forceps)

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

**Name:** Conventional double bite forcep

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Comparison of the histological quality of specimens retrieved with multiple bite forceps compared to double bite forceps

**Measure:** Histological quality

**Time Frame:** Duration of endoscopy and pathological assessment of specimens

#### Secondary Outcomes

**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

**Measure:** Time duration

**Time Frame:** Duration of endoscopy

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kingston

**Country:** Canada

**Facility:** Hotel Dieu Hospital

**State:** Ontario

**Zip:** K7L 5G2

#### Overall Officials

**Official 1:**

**Affiliation:** Queen's University

**Name:** Lawrence C Hookey, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 21601201

**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.

**PMID:** 17087937

**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.

**PMID:** 23609613

**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.

**PMID:** 16996354

**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.

**PMID:** 11677476

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008286

- Term: Malabsorption Syndromes

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5696

- Name: Celiac Disease

- Relevance: HIGH

- As Found: Celiac Disease

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M11278

- Name: Malabsorption Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002446

- Term: Celiac Disease

### Misc Info Module

- Version Holder: 2024-05-24
