Condition category
Digestive System
Date applied
04/04/2018
Date assigned
23/04/2018
Last edited
23/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Barrett's esophagus is a condition of the lower part of the esophagus (food pipe). Repeated damage, caused by backflowing stomach acid over many years, can eventually cause changes in the cells that line the esophagus. These abnormal cells are at an increased risk of abnormal growth of tissue (known as neoplasia) and might become cancerous. Endoscopic resection (ER) is a procedure to remove abnormal tissue in Barrett's esophagus. However, accurate evaluation of an ER tissue sample (specimen) under the microscope can be challenging. The preferred method for handling of ER specimens remains unknown.
Therefore the aim of this study is to compare three different methods of specimen handling for adequate evaluation of all factors, and time required for handling.

Who can participate?
Adults with Barrett's esophagus related neoplasia

What does the study involve?
ER specimens collected from participants are randomly allocated to one of three methods of specimen handling. There is no further follow up with participants.

What are the possible benefits and risks of participating?
There are no benefits or risks for the participant.

Where is the study run from?
1. St. Antonius Hospital Nieuwegein (Netherlands)
2. Academic Medical Center Amsterdam (Netherlands)
3. Catharina Hospital Eindhoven (Netherlands)

When is the study starting and how long is it expected to run for?
September 2015 to June 2017

Who is funding the study?
St. Antonius Research Fund (Netherlands)

Who is the main contact?
1. Dr. A. Overwater (Public)
2. Prof. B.L.A.M. Weusten (Scientific)

Trial website

Contact information

Type

Public

Primary contact

Ms Anouk Overwater

ORCID ID

http://orcid.org/0000-0001-8356-5776

Contact details

St. Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Type

Scientific

Additional contact

Prof Bas Weusten

ORCID ID

http://orcid.org/0000-0001-9468-4578

Contact details

St. Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15.0209

Study information

Scientific title

New pathology box for specimen preparation after EMR: a randomized controlled trial of three different ways of specimen handling (the Cassette study)

Acronym

n/a

Study hypothesis

The aim of this study is to compare three different methods of specimen handling for:
1) enabling adequate evaluation of all clinically relevant histologic parameters of endoscopic resection specimens with no suspicion of submucosal invasion
2) required time for specimen handling

Ethics approval

Ethical approval not required: The Medical Ethics Review Committee of the Academic Medical Center Amsterdam evaluated the study protocol and stated that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study, ref: W15_172 # 15.0209

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available.

Condition

Barrett's esophagus related neoplasia

Intervention

Specimens are collected from participants with Barrett's Esophagus related neoplasia that have an endoscopic resection. They are randomly allocated to one of three different methods of specimen handling:
1. Pinning on paraffin: The pinning method comprises smooth stretching of the endoscopic mucosal resection (EMR) specimen and pinning it out on cork or paraffin.
2. Cassette technique: The cassette (Boston Scientific, Marlborough, U.S.A.) is a small box in which an EMR specimen can be enclosed after stretching it out on paper. By closing the cassette, gentle pressure is applied on the specimen during the process of formalin fixation to prevent curling of the lateral margins of the resection specimen.
3. Direct fixation in formalin: Direct fixation of the EMR specimen in formalin with no prior handling.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The overall ability to assess all relevant histopathological parameters is assessed using a 5-point Likert scale during central revision by 2 blinded Barrett’s esophagus (BE) expert pathologists after inclusion of all EMR specimens is completed and all primary histopathologic evaluations in the treating centers are finished

Secondary outcome measures

1. The ability to adequately assess the vertical and lateral resection margins, tumor differentiation grade, tumor infiltration depth and lymphovascular invasion is assessed using a 5-point Likert scale during central revision by 2 blinded Barrett’s esophagus (BE) expert pathologists after inclusion of all EMR specimens is completed and all primary histopathologic evaluations in the treating centers are finished.
2. Time necessary for handling of the endoscopic resected specimen measured in seconds directly after the endoscopic resection is completed.

Overall trial start date

27/09/2015

Overall trial end date

01/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Endoscopic resection specimens of Barrett’s esophagus related neoplasia
2. No suspicion of submucosal invasion acquired by Multi-band mucosectomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 endoscopic mucosal resection specimens

Participant exclusion criteria

1. Poor tumor differentiation grade (if known beforehand)
2. Suspicion of submucosal invasion during endoscopy

Recruitment start date

01/01/2016

Recruitment end date

01/01/2017

Locations

Countries of recruitment

Netherlands

Trial participating centre

St. Antonius Hospital
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Trial participating centre

Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Trial participating centre

Catharina Hospital Eindhoven
Michelangelolaan 2
Eindhoven
5623 EJ
Netherlands

Sponsor information

Organisation

St. Antonius Hospital Nieuwegein

Sponsor details

Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St. Antonius Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submission of manuscript to a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from B.L.A.M. Weusten, b.weusten@antoniusziekenhuis.nl

Additional documentation:
Full trial protocol is available upon request by the principle investigator as above.

Intention to publish date

30/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes