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

Small Intestinal Neuroendocrine Tumor Clinical Trial

— SI-NET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03442959
• Other study ID #: PO17142
• Status: Recruiting
• Start date: July 3, 2018
• Est. completion date: January 3, 2025

Study information

• Verified date: February 2018
• Source: CHU de Reims
• Contact: Sophie DEGUELTE
• Phone: 03 26 83 27 78
• Email: sdeguelte[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 3, 2025
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Small Intestinal Neuroendocrine Tumor

Intervention

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)

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death due to Small Intestinal neuroendocrine Tumor	5 years