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Gastric conduit perfusion assessment by ICG fluorescence in minimally invasive esophagectomy


- candidate number24734
- NTR NumberNTR6032
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2016
- Secondary IDsNL58179.091.16 
- Public TitleGastric conduit perfusion assessment by ICG fluorescence in minimally invasive esophagectomy
- Scientific TitleGastric conduit perfusion assessment by ICG fluorescence in minimally invasive esophagectomy; an exploratory study
- ACRONYMGAP trial
- hypothesisICG can be used to assess the gastric conduit perfusion during esophagectomy
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria All patients eligible for minimally invasive esophagectomy for esophageal cancer, with gastric conduit reconstruction and intra-thoracic gastro-esophageal anastomosis
Aged 18 years or older
Providing informed consent
- Exclusion criteria Known pregnancy or breastfeeding
Known iodine, shellfish or ICG hypersensitivity
Known hyper-thyroidism
Known liver or renal insufficiency
Unable to provide informed consent
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-sep-2016
- planned closingdate1-mrt-2017
- Target number of participants20
- InterventionsNear-infrared fluorescence (NIRF) intra-operative imaging after administration of ICG
- Primary outcomeTo explore the feasibility and added value of intra-operative NIRF imaging to assess gastric conduit perfusion in minimally invasive esophagectomy.
- Secondary outcomeIndentify the increase in procedure time, post-operative anastomotic leakage, patient and tumor characteristics
- Timepoints-
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Didi de Gouw
- CONTACT for SCIENTIFIC QUERIES Didi de Gouw
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryAnastomotic leakage after esophagectomy is an early post-operative complication and a major cause of morbidity and mortality. Impaired arterial bloodflow of the gastric conduit is thought to be the most important cause of anastomotic leakage. Better assessment of gastric conduit perfusion and identification of the ideal level of anastomosis is needed. A promosing technique to assess the gastric conduit perfusion intra-operatively is near-infrared fluorescence (NIRF) imaging after injection with indocyanine green (ICG).
- Main changes (audit trail)
- RECORD4-aug-2016 - 19-okt-2016


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