Preoperative Imaging in Patients With Small Bowel Neuroendocrine Tumors

NCT ID: NCT05246319

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2025-02-11

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.

Conditions

Neuroendocrine Tumors; Small Intestinal NET; Lymph Node Metastasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with small intestine neuroendocrine tumors

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

preoperative imaging

Intervention Type: DIAGNOSTIC_TEST

evaluation of preoperative imaging (versus nodes observed on pathology)

Interventions

preoperative imaging

evaluation of preoperative imaging (versus nodes observed on pathology)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laurent BRUNAUD

OTHER

Sponsor Role: lead

Responsible Party

Laurent BRUNAUD

PI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

laurent Brunaud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

CHRU Nancy

Nancy, , France

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

Nancy, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 35434838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24050954 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28448665 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30054825 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2443618 (View on PubMed)

Other Identifiers

2021PI126

Identifier Type: -

Identifier Source: org_study_id