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Trial record 91 of 2732 for:    Neuroendocrine Tumors | Neuroendocrine Tumors

PreOPerative Imaging of NeuroEndocrine Tumors (POPINET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03958188
Recruitment Status : Active, not recruiting
First Posted : May 21, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment
Neuro-endocrine Tumors Small Intestine Cancer Other: Standardized computerized tomography (CT) reading grid for preoperative planning

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Retrospective
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


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:

  • Age
  • Sex
  • Symptomatology (abdominal pain, diarrhea, carcinoid flush, digestive bleeding, weight loss, occlusive syndrome)
  • Blood Chromogranine A and urinary 5-hydroxyindoleacetic acid (5-HIAA)
  • Carcinoid valvulopathy
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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients at least 18 years old with small intestine neuro-endocrine tumors (NET)
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Hôpital Edouard Herriot
Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Romain L'Huillier Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03958188     History of Changes
Other Study ID Numbers: POPINET
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Intestinal tumors
Computerized Tomography

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Neoplasms
Endocrine Gland Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine System Diseases