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

NCT02657044 | Unknown

• 2 other identifiers: 15-610/DTDM-H1/8051
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasms

Keywords

EMR; ESD; endoscopic mucosal resection; endoscopic submucosal resection; colorectal adenomas

Outcome Measures

Primary Outcomes (1)

• Recurrence rate at follow-up colonoscopy after 6 months

  Observed from resected residual disease or, if not present, from biopsies of the scar

  6 months

Secondary Outcomes (6)

• Long-term recurrence rate at follow-up colonoscopy after 36 months

  36 months

• Health care resource utilization and consts

  36 months

• Perceived burden and quality of life among patients

  36 months

• Complication rate

  30 days

• Surgical referral rate

  36 months

Study Arms (2)

EMR

ACTIVE COMPARATOR

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

Procedure: EMR

ESD

ACTIVE COMPARATOR

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

Procedure: ESD

Interventions

EMR PROCEDURE

Also known as: Endoscopic Mucosal Resection

EMR

ESD PROCEDURE

Also known as: Endoscopic Submucosal Dissection

ESD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Comprehensive Cancer Centre The Netherlands: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508GA, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 27229709 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• L.M.G. Moons, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• A.D. Koch, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Y. Backes, MD

CONTACT

003187550722; y.backes@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. L.M.G. Moons, Principal Investigator

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 15, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2020
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

NL (1)