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Minimally invasive esophageal resection for esophageal carcinoma: Restoring continuity of the gastro-intestinal tract at the level of the thorax or at the neck.


- candidate number15934
- NTR NumberNTR4333
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-dec-2013
- Secondary IDs
- Public TitleMinimally invasive esophageal resection for esophageal carcinoma: Restoring continuity of the gastro-intestinal tract at the level of the thorax or at the neck.
- Scientific TitleIntrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: a randomized controlled trial
- ACRONYMICAN trial
- hypothesisIntrathoracic anastomosis is associated with a reduction of anastomotic leakage requiring re-intervention
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Minimally invasive surgical procedures, Cervical
- Inclusion criteria- Age >= 18 years.
- Histologically proven esophageal carcinoma from below the carina to the gastro-esophageal junction (Siewert 2).
- Resectable tumour (T1b-34a N0-3 M0).
- Mental, physical and geographical ability to undergo treatment and follow-up.
- Ability to provide written informed consent.
- Exclusion criteria- Previous major gastric or major thoracic surgery.
- Secondary, prognosis determining malignancy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate1-okt-2019
- Target number of participants200
- InterventionsMIE with cervical anastomosis (control group) is compared to MIE with intrathoracic anastomosis (intervention group).
- Primary outcomeAnastomotic leakage for which endoscopic, radiologic or surgical intervention is required.
- Secondary outcomeQuality of life, benign anastomotic strictures requiring dilatation, reintervention, pulmonary complications, length of stay, mortality, and costs.
- TimepointsFollow up: two years
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. F. van Workum
- CONTACT for SCIENTIFIC QUERIESDrs. F. van Workum
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryRationale: Currently, a cervical esophagogastric anastomosis (CEA) is most often performed after minimally invasive esophagectomy (MIE). However, it is associated with a considerable incidence of anastomotic leakage requiring reintervention and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) after MIE might reduce anastomotic leakage incidence, improve functional results and lower costs. Objective: To compare anastomotic leakage, quality of life and other postoperative morbidity and mortality of Intrathoracic versus Cervical Anastomosis after MIE (ICAN trial). Study design: The ICAN trial is designed as an open randomized controlled multi- center superiority trial. Study population: All patients aged >=18 years with esophageal carcinoma below the level of the carina planned for curative resection. Intervention: MIE with IEA (intervention group) is compared to MIE with CEA (control group). Main study parameters/endpoints: Primary outcome parameter: anastomotic leakage, for which endoscopic, radiologic or surgical reintervention is required. Secondary outcome parameters (amongst others): Benign anastomotic strictures requiring dilatation, quality of life, reintervention rate, pulmonary complications, length of stay, mortality, and costs. Sample size: 200 patients. Follow up: 2 years
- Main changes (audit trail)
- RECORD23-dec-2013 - 7-feb-2016


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