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Preoperative Imaging in Patients With Small Bowel Neuroendocrine Tumors (TEGRELE)

L

Laurent BRUNAUD

Status

Completed

Conditions

Small Intestinal NET
Lymph Node Metastasis
Neuroendocrine Tumors

Treatments

Diagnostic Test: preoperative imaging

Study type

Observational

Funder types

Other

Identifiers

NCT05246319
2021PI126

Details and patient eligibility

About

Digestive NETs are the second most common malignant digestive tumor after adenocarcinoma. The most common gastrointestinal NETs arise from the small intestine. These tumors have a high lymph node and distant metastatic potential (hepatic, pulmonary, etc.). Their management is essentially surgical and the extent of the resection essentially depends on preoperative data from conventional and isotopic imaging.

The goal of surgical resection is to remove the portion of the small intestine carrying the tumour(s) with healthy margins (so-called R0 resection) and affected lymph nodes in the mesentery (lymph node dissection). The extent of lymph node dissection, sometimes significant, exposes you to the risk of short hail with its own complications (malnutrition, diarrhoea, etc.). Consequently, an analysis of the benefits and risks between the interest of an extensive and oncological resection (R0) and the risks of short bowel must be carried out for each patient.

The reference examination to define lymph node involvement is determined by the histological examination of the resected surgical specimen (reference examination). The preoperative evaluation of lymph node extension is done by preoperative abdominal CT scan. However, the preoperative CT scan is not always consistent (sensitivity and specificity) with the pathology data (reference examination). For about 5 years, isotopic imaging (DOPA-PET and DOTATOC) has become feasible and could improve the quality of preoperative evaluation of lymph node extension. Consequently, the aim of this study is to determine the contribution of isotopic imaging (DOPA-PET and DOTATOC) in the preoperative evaluation of lymph node extension.

Full description

Digestive neuroendocrine tumors (NET) are developed from neuroendocrine cells, of epithelial origin, scattered throughout the digestive tract. These tumors form a heterogeneous group defined according to the site of origin, the cell type affected, the functional character or not, the cell differentiation (morphology), and finally the potential for tumor progression and aggressiveness. Digestive NETs are the second most common malignant digestive tumor after adenocarcinoma. The most common gastrointestinal NETs arise from the small intestine. These tumors have a high lymph node and distant metastatic potential (hepatic, pulmonary, etc.). Their management is essentially surgical and the extent of the resection essentially depends on preoperative data from conventional and isotopic imaging. The goal of surgical resection is to remove the portion of the small intestine carrying the tumour(s) with healthy margins (so-called R0 resection) and affected lymph nodes in the mesentery (lymph node dissection). The extent of lymph node dissection, sometimes significant, exposes you to the risk of short hail with its own complications (malnutrition, diarrhoea, etc.). Consequently, an analysis of the benefits and risks between the interest of an extensive and oncological resection (R0) and the risks of short bowel must be carried out for each patient.

The reference examination to define lymph node involvement is determined by the histological examination of the resected surgical specimen (reference examination). The preoperative evaluation of lymph node extension is done by preoperative abdominal CT scan. However, the preoperative CT scan is not always consistent (sensitivity and specificity) with the pathology data (reference examination). For about 5 years, isotopic imaging (DOPA-PET and DOTATOC) has become feasible and could improve the quality of preoperative evaluation of lymph node extension. Consequently, the aim of this study is to determine the contribution of isotopic imaging (DOPA-PET and DOTATOC) in the preoperative evaluation of lymph node extension.

Enrollment

50 patients

Sex

All

Ages

16 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with neuroendocrine tumors who underwent a scheduled surgical procedure for small bowel resection

Exclusion criteria

  • patients without preoperative CT scan
  • patients with abdominal resection performed in emergency

Trial design

50 participants in 1 patient group

Patients with small intestine neuroendocrine tumors
Description:
Evaluation of preoperative abdominal imaging in patients who underwent an a resection for neuroendocrine tumors
Treatment:
Diagnostic Test: preoperative imaging

Trial contacts and locations

2

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Central trial contact

laurent Brunaud, MD, PhD

Data sourced from clinicaltrials.gov

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