Neoplasms

All Conditions

Digestive System Diseases

Adenoma

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

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

Y. Backes, MD

Yara Backes, MD

L.M.G. Moons, MD, PhD

A.D. Koch, MD, PhD

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.

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

Multicenter, Randomised Controlled Trial Comparing Endoscopic Mucosal Resection (EMR) And Endoscopic Submucosal dissecTIon (ESD) for Resection of Large Distal Non-pedunculated Colorectal Adenomas (MATILDA-trial)

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

Healthcare costs will be calculated by multiplying used healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional costs per QALY.

Measurement of the patients' burden of ESD versus EMR will be evaluated with regard to colorectal cancer anxiety, burden of the procedure itself, functional complaints and overall quality of life. Meaurement will be performed using validated questionnaires.

Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.

Defined as the number of patients that are referred for surgical management at 36 months

Defined as dysplasia free vertical and lateral resection margins at histology

Comprehensive Cancer Centre The Netherlands

UMC Utrecht

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

Symptoms and General Pathology

Recurrence

Adenocarcinoma

Disease Attributes

Anti-Infective Agents

All Drugs and Chemicals

Formaldehyde

Survivors of T1 colorectal cancer who developed recurrent colorectal cancer within 36 months from primary tumor treatment, in the first cohort

Survivors of T1 colorectal cancer who did not develop recurrent colorectal cancer within 36 months from primary tumor treatment, in the first cohort

Survivors of T1 colorectal cancer who developed recurrent colorectal cancer within 36 months from primary tumor treatment, in the second cohort

Survivors of T1 colorectal cancer who did not develop recurrent colorectal cancer within 36 months from primary tumor treatment, in the second cohort

A panel of microRNA and messenger RNA, whose expression level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor, with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)

Tw1CE

Ajay Goel, PhD

Takayuki Noma, MD

Alessandro Mannucci

Mitsuo Shimada, PhD

Katsuki Miyazaki

Yuma Wada, PhD

Mistuo Shimada, PhD

Maria Pellise

Karmele Saez de Gordoa

María Daca

Francesc Balaguer

Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.

This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.

The incidence of invasive submucosal colorectal cancer (T1 CRC) is increasing, likely as a reflection of improved screening and endoscopy use. Current treatment options for T1 CRC focus on less invasive methods (i.e., endoscopic submucosal dissection), and treatment decisions are based on the risk of lymph node metastasis (LNM). Up to 70-80% of T1 CRC patients may undergo surgery, with adjuvant chemotherapy recommended only for those with LNM.

However, current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone. This results in the overtreatment of many patients, especially those that are currently defined as 'high-risk' T1 CRC. Existing surveillance methods may not adequately predict the prognosis of T1 CRC, lacking established biomarkers for assessing disease-free survival.

This study seeks to validate tissue-based biomarkers (micro-RNA and messenger RNA) that are associated with tumor recurrence after curative resection. The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy. Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC, highlighting their potential as biomarkers for disease progression.

Formalin-fixed, paraffin-embedded slide from the primary tumor

Predicting Local and Distant Recurrence in T1 Colorectal Cancer

Predicting Recurrence After Curative-Intent Resection of T1 Colorectal Cancer With Transcriptomics

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.

Time from curative-intent resection to the development of recurrence (or death)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas	NCT02657044	Colorectal Neop...	EMR ESD	18 Years -	UMC Utrecht
Predicting Local and Distant Recurrence in T1 Colorectal Cancer	NCT06314971	Colorectal Canc... Colorectal Neop... Colorectal Aden... Colorectal Canc... Colorectal Neop... Colorectal Canc...	Tw1CE	18 Years -	City of Hope Medical Center
EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas	NCT02657044	Colorectal Neop...	EMR ESD	18 Years -	UMC Utrecht
Predicting Local and Distant Recurrence in T1 Colorectal Cancer	NCT06314971	Colorectal Canc... Colorectal Neop... Colorectal Aden... Colorectal Canc... Colorectal Neop... Colorectal Canc...	Tw1CE	18 Years -	City of Hope Medical Center
EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas	NCT02657044	Colorectal Neop...	EMR ESD	18 Years -	UMC Utrecht

Spots Global Cancer Trial Database for endoscopic submucosal resection