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EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas

NCT ID: NCT02657044

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-12-31

Brief Summary

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Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.

Detailed Description

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Conditions

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Colorectal Neoplasms

Keywords

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EMR ESD endoscopic mucosal resection endoscopic submucosal resection colorectal adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EMR

In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.

Group Type ACTIVE_COMPARATOR

EMR

Intervention Type PROCEDURE

ESD

In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.

Group Type ACTIVE_COMPARATOR

ESD

Intervention Type PROCEDURE

Interventions

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EMR

Intervention Type PROCEDURE

ESD

Intervention Type PROCEDURE

Other Intervention Names

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Endoscopic Mucosal Resection Endoscopic Submucosal Dissection

Eligibility Criteria

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Inclusion Criteria

* non-pedunculated polyp larger than 20 mm in the rectum, sigmoid or descending colon found during colonoscopy
* indication for endoscopic treatment
* ≥18 years old
* Written informed consent

Exclusion Criteria

* suspicion of malignancy, as determined by endoscopic findings (invasive Kudo pit pattern, Hiroshima type C) or proven malignancy at histology
* prior endoscopic resection attempt
* presence of synchronous distal advanced carcinoma that requires surgical resection
* the risk exceeds the benefit of endoscopic treatment, such as patient's with an extremely poor general condition or a very short life expectancy
* the inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Comprehensive Cancer Centre The Netherlands

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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L.M.G. Moons

dr. L.M.G. Moons, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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L.M.G. Moons, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

A.D. Koch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Y. Backes, MD

Role: CONTACT

Phone: 003187550722

Email: [email protected]

Facility Contacts

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Yara Backes, MD

Role: primary

References

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Backes Y, Moons LM, van Bergeijk JD, Berk L, Ter Borg F, Ter Borg PC, Elias SG, Geesing JM, Groen JN, Hadithi M, Hardwick JC, Kerkhof M, Mangen MJ, Straathof JW, Schroder R, Schwartz MP, Spanier BW, de Vos Tot Nederveen Cappel WH, Wolfhagen FH, Koch AD. Endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection (ESD) for resection of large distal non-pedunculated colorectal adenomas (MATILDA-trial): rationale and design of a multicenter randomized clinical trial. BMC Gastroenterol. 2016 May 26;16(1):56. doi: 10.1186/s12876-016-0468-6.

Reference Type DERIVED
PMID: 27229709 (View on PubMed)

Other Identifiers

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TDM-H1/8051

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15-610/D

Identifier Type: -

Identifier Source: org_study_id