title: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT02657044 (Clinicaltrials.gov), registered January 8, 2016.
authors.affiliation: Department of Gastroenterology & Hepatology, University Medical Center Utrecht, Heidelberglaan 100, 3508, GA, Utrecht, Netherlands.
authors.forename: Y
authors.initials: Y
authors.lastname: Backes
authors.affiliation: Department of Gastroenterology & Hepatology, University Medical Center Utrecht, Heidelberglaan 100, 3508, GA, Utrecht, Netherlands. l.m.g.moons@umcutrecht.nl.
authors.forename: L M G
authors.initials: LM
authors.lastname: Moons
authors.affiliation: Department of Gastroenterology & Hepatology, Gelderse Vallei, Ede, Netherlands.
authors.forename: J D
authors.initials: JD
authors.lastname: van Bergeijk
authors.affiliation: Department of Gastroenterology & Hepatology, Sint Franciscus, Rotterdam, Netherlands.
authors.forename: L
authors.initials: L
authors.lastname: Berk
authors.affiliation: Department of Gastroenterology & Hepatology, Deventer Hospital, Deventer, Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Ter Borg
authors.affiliation: Department of Gastroenterology & Hepatology, Ikazia, Rotterdam, Netherlands.
authors.forename: P C J
authors.initials: PC
authors.lastname: Ter Borg
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: S G
authors.initials: SG
authors.lastname: Elias
authors.affiliation: Department of Gastroenterology & Hepatology, Diakonessenhuis, Utrecht, Netherlands.
authors.forename: J M J
authors.initials: JM
authors.lastname: Geesing
authors.affiliation: Department of Gastroenterology & Hepatology, Sint Jansdal, Harderwijk, Netherlands.
authors.forename: J N
authors.initials: JN
authors.lastname: Groen
authors.affiliation: Department of Gastroenterology & Hepatology, Maasstad hospital, Rotterdam, Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Hadithi
authors.affiliation: Department of Gastroenterology & Hepatology, Leiden University Medical Center, Leiden, Netherlands.
authors.forename: J C H
authors.initials: JC
authors.lastname: Hardwick
authors.affiliation: Department of Gastroenterology & Hepatology, Groene Hart Hospital, Gouda, Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Kerkhof
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: M J J
authors.initials: MJ
authors.lastname: Mangen
authors.affiliation: Department of Gastroenterology & Hepatology, Máxima Medical Center, Eindhoven, Netherlands.
authors.forename: J W A
authors.initials: JW
authors.lastname: Straathof
authors.affiliation: Department of Gastroenterology & Hepatology, Gelre Hospital, Apeldoorn, Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Schröder
authors.affiliation: Department of Gastroenterology & Hepatology, Meander Medical Center, Amersfoort, Netherlands.
authors.forename: M P
authors.initials: MP
authors.lastname: Schwartz
authors.affiliation: Department of Gastroenterology & Hepatology, Rijnstate hospital, Arnhem, Netherlands.
authors.forename: B W M
authors.initials: BW
authors.lastname: Spanier
authors.affiliation: Department of Gastroenterology & Hepatology, Isala, Zwolle, Netherlands.
authors.forename: W H
authors.initials: WH
authors.lastname: de Vos Tot Nederveen Cappel
authors.affiliation: Department of Gastroenterology & Hepatology, Albert Schweitzer, Dordrecht, Netherlands.
authors.forename: F H J
authors.initials: FH
authors.lastname: Wolfhagen
authors.affiliation: Department of Gastroenterology & Hepatology, Erasmus Medical Center, Rotterdam, Netherlands.
authors.forename: A D
authors.initials: AD
authors.lastname: Koch
mesh_terms: D000236:Adenoma / Q000473:pathology / Q000601:surgery*; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery*; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D000069916:Endoscopic Mucosal Resection / Q000009:adverse effects / Q000191:economics* / Q000379:methods*; D017048:Health Care Costs; D006801:Humans; D009364:Neoplasm Recurrence, Local; D011788:Quality of Life
keywords: Colonoscopy; Colorectal adenoma; Endoscopic mucosal resection; Endoscopic submucosal dissection; Randomized clinical trial