TEGRELE: Preoperative Imaging in Patients With Small Bowel Neuroendocrine Tumors

Sponsor
Laurent BRUNAUD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246319
Collaborator
(none)
50
2
132
25
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: preoperative imaging

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Preoperative Imaging (CT Scan, DOPA-PET and DOTATOC) in Patients With Small Bowel Neuroendocrine Tumors
Actual Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients with small intestine neuroendocrine tumors

Evaluation of preoperative abdominal imaging in patients who underwent an a resection for neuroendocrine tumors

Diagnostic Test: preoperative imaging
evaluation of preoperative imaging (versus nodes observed on pathology)

Outcome Measures

Primary Outcome Measures

  1. mesenteric lymph nodes [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 Outcome Measures

  1. comparison [before surgical procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 95 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Nancy Nancy France 54000
2 CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage) Nancy France 54511

Sponsors and Collaborators

  • Laurent BRUNAUD

Investigators

  • Principal Investigator: laurent Brunaud, MD, PhD, CHRU Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Laurent BRUNAUD, PI, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05246319
Other Study ID Numbers:
  • 2021PI126
First Posted:
Feb 18, 2022
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Laurent BRUNAUD, PI, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022