Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| OTHER | Standardized computerized tomography (CT) reading grid for preoperative planning | Using 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.