PreOPerative Imaging of NeuroEndocrine Tumors (POPINET)
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|ClinicalTrials.gov Identifier: NCT03958188|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2019
Last Update Posted : May 28, 2019
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.
|Condition or disease||Intervention/treatment|
|Neuro-endocrine Tumors Small Intestine Cancer||Other: Standardized computerized tomography (CT) reading grid for preoperative planning|
|Study Type :||Observational|
|Actual Enrollment :||47 participants|
|Official Title:||Assessment of an Optimized and Standardized Computerised Tomography (CT) Reading Grid for Preoperative Planning Improvement of Small Bowel Neuroendocrine Tumours (NET).|
|Actual Study Start Date :||March 31, 2019|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Patients who have undergone pre-operated computerized tomography (CT) imaging for a subsequently operated Neuro-endocrine tumor (NET).
Clinical data collected for each patients:
Other: Standardized computerized tomography (CT) reading grid for preoperative planning
Using the standardized reading grid, the following data will be collected:
The anonymized CT exam will be reviewed by an expert radiologist and a radiology resident from imaging department of the Hospital.
- Standardization of a reading grid for PreOPerative Imaging of NeuroEndocrine Tumors [ Time Frame: 7 months ]Improve the semiological description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging technique with a standardized reading grid in order to plan the best surgical procedure which allows maintaining a minimal length of small intestine needed to a satisfying quality of life and nutritional status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958188
|Hôpital Edouard Herriot|
|Lyon, France, 69437|
|Principal Investigator:||Romain L'Huillier||Hospices Civils de Lyon|