Dataset Information

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.

ABSTRACT:

Background

Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal polyps. However, in large lesions EMR can often only be performed in a piecemeal fashion resulting in relatively low radical (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. We aim to evaluate the (cost-)effectiveness of ESD against EMR on both short (i.e. 6 months) and long-term (i.e. 36 months). We hypothesize that in the short-run ESD is more time consuming resulting in higher healthcare costs, but is (cost-) effective on the long-term due to lower patients burden, a higher number of R0-resections and lower recurrence rates with less need for repeated procedures.

Methods

This is a multicenter randomized clinical trial in patients with a non-pedunculated polyp larger than 20 mm in the rectum, sigmoid, or descending colon suspected to be an adenoma by means of endoscopic assessment. Primary endpoint is recurrence rate at follow-up colonoscopy at 6 months. Secondary endpoints are R0-resection rate, perceived burden and quality of life, healthcare resources utilization and costs, surgical referral rate, complication rate and recurrence rate at 36 months. Quality-adjusted-life-year (QALY) will be estimated taking an area under the curve approach and using EQ-5D-indexes. 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.

Discussion

If this trial confirms ESD to be favorable on the long-term, the burden of extra colonoscopies and repeated procedures can be prevented for future patients.

Trial registration

NCT02657044 (Clinicaltrials.gov), registered January 8, 2016.

SUBMITTER: Backes Y

PROVIDER: S-EPMC4882830 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Publications

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.

Backes Y Y Moons L M G LM van Bergeijk J D JD Berk L L Ter Borg F F Ter Borg P C J PC Elias S G SG Geesing J M J JM Groen J N JN Hadithi M M Hardwick J C H JC Kerkhof M M Mangen M J J MJ Straathof J W A JW Schröder R R Schwartz M P MP Spanier B W M BW de Vos Tot Nederveen Cappel W H WH Wolfhagen F H J FH Koch A D AD

BMC gastroenterology 20160526 1

<h4>Background</h4>Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal polyps. However, in large lesions EMR can often only be performed in a piecemeal fashion resulting in relatively low radical (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 ...[more]

PMID: 27229709

Similar Datasets

Project description:BackgroundEndoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) are used to remove esophagogastric junction (EGJ) neoplasm. This study aimed to compare feasibility, safety, and effectiveness between ESD and EMR to help endoscopists choose treatment methods.MethodsA total of 130 patients with EGJ neoplasm underwent endoscopic resection, including 52 patients with EMR and 78 patients with ESD. Cap-assisted EMR (EMRC) was performed with typical sequences. Larger lesions required removal in multiple pieces (i.e., piecemeal EMR). The ESD procedures were included that marking the periphery of the lesion, submucosa injected, circumferentially cutting and submucosal dissection. Resection time, adverse events, en bloc resection rate, R0 resection rate and recurrence rate were compared between the two groups.ResultsThere were no significant differences in demographic characteristics or histopathological features between the two groups. Resection time was longer in the ESD group than in the EMR group (64.4±33.9 vs. 22.1±8.0 minutes; P<0.01). Adverse events were more common in the ESD group than in the EMR group (16.7% vs. 3.8%; P=0.03), including bleeding (7.7% vs. 3.8%), perforation (5.1% vs. 0%) and stenosis (5.1% vs. 0%). The en bloc resection rate and R0 resection rate were much higher in the ESD group than in the EMR group (98.7% and 92.3% vs. 23.1% and 23.1%, respectively; P<0.01). The 5-year overall survival rate and disease-free survival rate were 100% vs. 92.0% and 100% vs. 90.1% between the ESD and EMR groups, respectively (P=0.01 and P=0.01). The 5-year cancer-specific survival rate was 100% vs. 96.0% between the ESD and EMR groups (P=0.08). The recurrence rate was lower in the ESD group than in the EMR group (0% vs. 9.6%; P=0.01).ConclusionsESD is an acceptable first-line endoscopic treatment for type II EGJ neoplasm, however, it is time-consuming and has a higher rate of adverse events. Furthermore, EMR is a safe and alternative technique, particularly when EMR could achieve en bloc resection.

Project description:BackgroundIn the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden.MethodsMulticenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior.DiscussionThis is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future.Trial registrationNetherlands Trial Register, NL7083 , 06 July 2018.

Dataset Information

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.

Background

Methods

Discussion

Trial registration

Publications

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.

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