- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03958188
PreOPerative Imaging of NeuroEndocrine Tumors (POPINET)
Assessment of an Optimized and Standardized Computerised Tomography (CT) Reading Grid for Preoperative Planning Improvement of Small Bowel Neuroendocrine Tumours (NET).
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69437
- Hôpital Edouard Herriot
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with small intestine neuro-endocrine tumors (NET) operated in the digestive surgical service of the University Edouard Herriot hospital of Lyon (Pr. Gilles Poncet) between the 1st of January 2014 and the 31st of March 2019,
- Having done a preoperative thoraco-abdomino-pelvic scanner with arterial and portal sequences.
- Scanner imaging, operative report and anatomo-pathological report available
Exclusion Criteria:
- no Computerized Tomography (CT) images available
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients who have undergone pre-operated computerized tomography (CT) imaging for a subsequently operated Neuro-endocrine tumor (NET). Clinical data collected for each patients:
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardization of a reading grid for PreOPerative Imaging of NeuroEndocrine Tumors
Time Frame: 7 months
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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.
|
7 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Romain L'Huillier, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Intestinal Diseases
- Neuroendocrine Tumors
- Intestinal Neoplasms
- Endocrine Gland Neoplasms
Other Study ID Numbers
- POPINET
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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