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| ID | Type | Description | Link |
|---|---|---|---|
| TDM-H1/8051 | Other Grant/Funding Number | Dutch Cancer Society (DCS) |
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| Name | Class |
|---|---|
| Comprehensive Cancer Centre The Netherlands | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMR | Active Comparator | In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique. |
|
| ESD | Active Comparator | In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMR | Procedure |
|
| |
| ESD |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term recurrence rate at follow-up colonoscopy after 36 months | Observed from resected residual disease or, if not present, from biopsies of the scar | 36 months |
| Health care resource utilization and consts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Y. Backes, MD | Contact | 003187550722 | y.backes@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| L.M.G. Moons, MD, PhD | UMC Utrecht | Principal Investigator |
| A.D. Koch, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Recruiting | Utrecht | Utrecht | 3508GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27229709 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Procedure |
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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.
| 36 months |
| Perceived burden and quality of life among patients | 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. | 36 months |
| Complication rate | Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis. | 30 days |
| Surgical referral rate | Defined as the number of patients that are referred for surgical management at 36 months | 36 months |
| R0-resection rate | Defined as dysplasia free vertical and lateral resection margins at histology | 30 days |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |