How to handle endoscopic mucosal resection specimens: randomised controlled trial to compare three different specimen handling methods.
| ISRCTN | ISRCTN50525266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50525266 |
| Secondary identifying numbers | 15.0209 |
- Submission date
- 04/04/2018
- Registration date
- 23/04/2018
- Last edited
- 01/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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)
Contact information
Public
St. Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
 ORCID ID |
0000-0001-8356-5776 |
|---|
Scientific
St. Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
| ORCID ID |
0000-0001-9468-4578 |
|---|
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available. |
| Scientific title | New pathology box for specimen preparation after EMR: a randomized controlled trial of three different ways of specimen handling (the Cassette study) |
| Study acronym | n/a |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 27/09/2015 |
| Completion date | 01/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 endoscopic mucosal resection specimens |
| Key inclusion criteria | 1. Endoscopic resection specimens of Barrett’s esophagus related neoplasia 2. No suspicion of submucosal invasion acquired by Multi-band mucosectomy |
| Key exclusion criteria | 1. Poor tumor differentiation grade (if known beforehand) 2. Suspicion of submucosal invasion during endoscopy |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Nieuwegein
3435 CM
Netherlands
Amsterdam
1105 AZ
Netherlands
Eindhoven
5623 EJ
Netherlands
Sponsor information
Hospital/treatment centre
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
"ROR" |
https://ror.org/01jvpb595 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned submission of manuscript to a high-impact peer reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2019 | Yes | No |
Editorial Notes
01/04/2019: Publication reference added.
