POPINET: PreOPerative Imaging of NeuroEndocrine Tumors

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Unknown status
CT.gov ID
NCT03958188
Collaborator
(none)
47
1
9
5.2

Study Details

Study Description

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 Phase
  • Other: Standardized computerized tomography (CT) reading grid for preoperative planning

Study Design

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 :
Mar 31, 2019
Anticipated Primary Completion Date :
Jun 30, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Standardization of a reading grid for PreOPerative Imaging of NeuroEndocrine Tumors [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Edouard Herriot Lyon France 69437

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Romain L'Huillier, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03958188
Other Study ID Numbers:
  • POPINET
First Posted:
May 21, 2019
Last Update Posted:
May 28, 2019
Last Verified:
May 1, 2019
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2019