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UnknownNCT03958188

PreOPerative Imaging of NeuroEndocrine Tumors

Assessment of an Optimized and Standardized Computerised Tomography (CT) Reading Grid for Preoperative Planning Improvement of Small Bowel Neuroendocrine Tumours (NET).

Status
Unknown
Phase
Study type
Observational
Enrollment
47 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Neuro-endocrine tumours (NET) are the most frequent tumours of the small intestine. In spite of their small size, these tumours have the particularity of forming mesenteric metastasis and ganglionic secondary lesions along the superior mesenteric axis, which is in close proximity to the superior mesenteric artery (SMA). Surgery is the only curative treatment. The complete resection being a factor for good patient prognosis, risks of subsequent local complications (occlusion, bleeding) must be discussed. The limiting factor for resectability is arterial vascular invasion considering the risk of postoperative small bowel syndrome. At the moment, the choice of imaging examination and its protocol is not standardized, nor the description of the tumoral mesenteric and ganglionic extension, especially the criteria defining a lymph node as lymphadenopathy. In addition, the complexity of SMA's anatomy and the absence of criteria for arterial invasion defining arterial invasion may lead to a misinterpretation of the preoperative imaging , and thus to an incomplete planning of the surgical procedure. To correct this absence of radiological standardization, the investigating team has developed a reading grid for Computed Tomography (CT) aimed to facilitate preoperative planning of small bowel NET. The main objective of the current study is to improve the semiotic description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging examination and a standardized reading grid in order to plan the best surgical procedure which would allow maintaining a minimal length of small intestine needed to yield a satisfying quality of life and nutritional status. The secondary objective of this study is to evaluate the reproducibility of the standardized scanner's reading grid.

Conditions

Interventions

TypeNameDescription
OTHERStandardized computerized tomography (CT) reading grid for preoperative planningUsing the standardized reading grid, the following data will be collected: * Small Intestine: tumor, parietal thickening, occlusive syndrome, proximity of the tumor with the ileocecal valve. * Mesenteric mass: presence, size, shape, contours, calcifications, enhancement, superior mesenteric arterial invasion and number of non-invaded arterial arteries. * Mesentery: moniliform venous dilatations, combed appearance. * Duodenal invasion. * Lymphadenopathies (Mesenteric, Right mesocolic and Retropancreatic): presence, size, shape, enhancement The anonymized CT exam will be reviewed by an expert radiologist and a radiology resident from imaging department of the Hospital.

Timeline

Start date
2019-03-31
Primary completion
2019-06-30
Completion
2019-12-31
First posted
2019-05-21
Last updated
2019-05-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03958188. Inclusion in this directory is not an endorsement.