PreOPerative Imaging of NeuroEndocrine Tumors

Small Intestine Cancer Clinical Trial

— POPINET  

Official title:

Assessment of an Optimized and Standardized Computerised Tomography (CT) Reading Grid for Preoperative Planning Improvement of Small Bowel Neuroendocrine Tumours (NET).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03958188
• Other study ID #: POPINET
• Status: Active, not recruiting
• Start date: March 31, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Intestinal Neoplasms
• Neuro-endocrine Tumors
• Neuroendocrine Tumors
• Small Intestine Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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