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Resection of the Primary Tumor vs no Resection in Asymptomatic Patients With Unresectable Synchronous Liver Metastases From siNEN

Resection of the Primary Tumor vs no Resection in Asymptomatic Patients With Unresectable Synchronous Liver Metastases From siNEN

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03442959
Acronym
SI-NET
Enrollment
50
Registered
2018-02-22
Start date
2018-07-03
Completion date
2025-01-03
Last updated
2018-07-12

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

Conditions

Small Intestinal Neuroendocrine Tumor

Keywords

Small intestine neuroendocrine tumor, palliative surgery

Brief summary

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.

Interventions

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)

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Death5 yearsDeath due to Small Intestinal neuroendocrine Tumor

Countries

France

Contacts

Primary ContactSophie DEGUELTE
sdeguelte@chu-reims.fr03 26 83 27 78
Backup ContactReza KIANMANESH
rkianmanesh@chu-reims.fr

Outcome results

None listed

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