How to handle endoscopic mucosal resection specimens: randomised controlled trial to compare three different specimen handling methods.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50525266

Enrollment

120

Registered

2018-04-23

Start date

2016-01-01

Completion date

Unknown

Last updated

2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus related neoplasia Digestive System Barrett's esophagus related neoplasia

Interventions

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 handli

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Contacts

Public ContactAnouk Overwater

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026