Preoperative Imaging in Patients With Small Bowel Neuroendocrine Tumors

NCT05246319 | Completed

• 1 other identifier: 2021PI126
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuroendocrine Tumors; Small Intestinal NET; Lymph Node Metastasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• mesenteric lymph nodes

  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).

  before surgical procedure

Secondary Outcomes (1)

• comparison

  before surgical procedure

Study Arms (1)

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

Interventions

preoperative imaging DIAGNOSTIC_TEST

evaluation of preoperative imaging (versus nodes observed on pathology)

Patients with small intestine neuroendocrine tumors

Eligibility Criteria

• Age: 16 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Laurent BRUNAUD: lead

Study Sites (2)

CHRU Nancy

Nancy, 54000, France

Location

CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

Nancy, 54511, France

Location

Related Publications (5)

• Deguelte S, Hammoutene C, Poncet G, Brunaud L, Perrier M, Kianmanesh R, Cadiot G. Concept of reintervention with thorough lymphadenectomy after suboptimal resection of small-intestine neuroendocrine neoplasms: A multicentre preliminary study. J Neuroendocrinol. 2022 Jun;34(6):e13117. doi: 10.1111/jne.13117. Epub 2022 Apr 18.

  PMID: 35434838 BACKGROUND

• Mocellin S, Nitti D. Gastrointestinal carcinoid: epidemiological and survival evidence from a large population-based study (n = 25 531). Ann Oncol. 2013 Dec;24(12):3040-4. doi: 10.1093/annonc/mdt377. Epub 2013 Sep 19.

  PMID: 24050954 BACKGROUND

• Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.

  PMID: 28448665 BACKGROUND

• Keck KJ, Maxwell JE, Utria AF, Bellizzi AM, Dillon JS, O'Dorisio TM, Howe JR. The Distal Predilection of Small Bowel Neuroendocrine Tumors. Ann Surg Oncol. 2018 Oct;25(11):3207-3213. doi: 10.1245/s10434-018-6676-2. Epub 2018 Jul 27.

  PMID: 30054825 BACKGROUND

• Moertel CG. Karnofsky memorial lecture. An odyssey in the land of small tumors. J Clin Oncol. 1987 Oct;5(10):1502-22. doi: 10.1200/JCO.1987.5.10.1502. No abstract available.

  PMID: 2443618 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• laurent Brunaud, MD, PhD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: January 1, 2012
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)