Resection of the Primary Tumor vs no Resection in Asymptomatic Patients With Unresectable Synchronous Liver Metastases From siNEN (SI-NET)

Small Intestinal neuroendocrine Tumors (SiNETs) incidence is rising. Most of siNETs primaries are localized in jejunum/ileum. At the diagnosis, 50-70% of them present either lymph node (LN) and/or liver metastases (LM). It is admitted that almost 30% of the patients present or will present primary complications. Primary complications include endoluminal obstruction and/or LN-fibrotic mesenteritis with occlusive symptoms, and less frequently haemorrhage and/or intestinal ischemia.However, it is not clear weather this affects patient with or without multiple liver metastases (LM). In this regard, many centres propose to perform primary resection even in patients presenting unresectable LM. Thus, systemic reviews suggest a possible benefit of the primary midgut siNETs resection even in patients with unresectable LM, there is no prospective randomized trial showing the benefit of primary resection in such patients especially those who are totally asymptomatic. Indeed, all retrospective published series have several limitations and the results should be therefore considered with caution.

Theoretical impact of "preventive" resection of midgut primaries in patients with unresectable LM and totally free of occlusive symptoms is controversial. Firstly, it is to avoid primary mechanical complications, and secondly to allow targeting therapeutics to the liver compartment. In this regard, in patients with synchronous unresectable LM from siNENs, ENETS, UKINETS, NANETS guidelines propose, in "a case-by-case" selective approach, the resection of the primary, while NCCN guidelines advocate to do not propose primary resection in such patient if they are free of symptoms with low tumor burden.

Study Overview

• Status: Recruiting
• Conditions: Small Intestinal Neuroendocrine Tumor
• Intervention / Treatment: Other: Data record

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Sophie DEGUELTE; Phone Number: 0033 03 26 83 27 78; Email: sdeguelte@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Sophie DEGUELTE; Phone Number: 03 26 83 27 78; Email: sdeguelte@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with newly diagnosis (in the last 6 months) of asymptomatic primary Si-NET with liver metastases considered as non-resectable between 01/02/2018 and 01/02/2019.

Description

Inclusion Criteria:

• 18 years old
• Patient with Si-NET and liver metastases considered as non-resectable
• Primary-related "asymptomatic" patient at diagnosis
• Diagnosed during the past 6 months
• No symptoms in relation with the primary or with mesenteric lesions
• Symptoms related to carcinoid syndrome allowed

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient with primary resection of the Small Intestinal TNE	Other: Data record; characteristics of patients, initial clinical presentation of TNE, management of TNE (primary tumor resection or conservative strategy), five years follow up (locoregional recurrence, complication due to the surgery, complications related to the conservative strategy, death)
patient without primary resection of the Small Intestinal TNE	Other: Data record; characteristics of patients, initial clinical presentation of TNE, management of TNE (primary tumor resection or conservative strategy), five years follow up (locoregional recurrence, complication due to the surgery, complications related to the conservative strategy, death)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death due to Small Intestinal neuroendocrine Tumor	5 years

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2018
• Primary Completion (ANTICIPATED): July 3, 2024
• Study Completion (ANTICIPATED): January 3, 2025

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (ACTUAL): February 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: palliative surgery; Small intestine neuroendocrine tumor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: PO17142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No