PreOPerative Imaging of NeuroEndocrine Tumors

NCT03958188 | Unknown

• 1 other identifier: POPINET
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuro-endocrine Tumors; Small Intestine Cancer

Keywords

Intestinal tumors; Computerized Tomography

Outcome Measures

Primary Outcomes (1)

• Standardization of a reading grid for PreOPerative Imaging of NeuroEndocrine Tumors

  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

Study Arms (1)

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

Interventions

Standardized computerized tomography (CT) reading grid for preoperative planning OTHER

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients at least 18 years old with small intestine neuro-endocrine tumors (NET)

You may qualify if:

• 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

You may not qualify if:

• no Computerized Tomography (CT) images available

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69437, France

Location

MeSH Terms

Conditions

Intestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Romain L'Huillier

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 21, 2019
• Study Start: March 31, 2019
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Locations

FR (1)