Preoperative Imaging in Patients With Small Bowel Neuroendocrine Tumors

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.

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Key information

Conditions

Neuroendocrine Tumors Lymph Node Metastasis Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Small Intestinal NET

Age range

16 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy, Nancy, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative imaging

Diagnostic Test

evaluation of preoperative imaging (versus nodes observed on pathology)

Primary outcomes

mesenteric lymph nodes

Time frame: before surgical procedure

Evaluate the number and location of affected mesenteric lymph nodes (defined by the pathology reference) which were visualized preoperatively by conventional imaging (CT) and isotopic imaging (DOPA-TEP and DOTATOC).

Secondary outcomes

comparison

Time frame: before surgical procedure

Compare conventional imaging (CT) and isotopic imaging (DOPA-TEP and DOTATOC) in terms of positive predictive value of nodal involvement

Sponsors and collaborators

Lead sponsor

Laurent BRUNAUD

Other

Registry information

Official study title

Evaluation of Preoperative Imaging (CT Scan, DOPA-PET and DOTATOC) in Patients With Small Bowel Neuroendocrine Tumors

Acronym: TEGRELE

Important dates

Study start: 2012
Primary completion: 2025
Study completion: 2025
First posted: Feb 18, 2022
Registry last updated: Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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