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Preoperative Imaging in Patients With Small Bowel Neuroendocrine Tumors

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05246319
Acronym
TEGRELE
Enrollment
50
Registered
2022-02-18
Start date
2012-01-01
Completion date
2025-02-11
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Node Metastasis, Neuroendocrine Tumors, Small Intestinal NET

Keywords

Neuroendocrine Tumors, Small Intestinal NET, Lymph Node Metastasis, Radionuclide Imaging, CT scan

Brief summary

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTpreoperative imaging

evaluation of preoperative imaging (versus nodes observed on pathology)

Sponsors

Laurent BRUNAUD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mesenteric lymph nodesbefore surgical procedureEvaluate 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

MeasureTime frameDescription
comparisonbefore surgical procedureCompare conventional imaging (CT) and isotopic imaging (DOPA-TEP and DOTATOC) in terms of positive predictive value of nodal involvement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026