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

NCT03442959 | Unknown

• 1 other identifier: PO17142
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Intestinal Neuroendocrine Tumor

Keywords

Small intestine neuroendocrine tumor; palliative surgery

Outcome Measures

Primary Outcomes (1)

• Death

  Death due to Small Intestinal neuroendocrine Tumor

  5 years

Study Arms (2)

patient with primary resection of the Small Intestinal TNE

Other: Data record

patient without primary resection of the Small Intestinal TNE

Other: Data record

Interventions

Data record OTHER

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 with primary resection of the Small Intestinal TNE; patient without primary resection of the Small Intestinal TNE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Interventions

Electronic Health Records

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Sophie DEGUELTE

CONTACT

03 26 83 27 78; sdeguelte@chu-reims.fr

Reza KIANMANESH

CONTACT

rkianmanesh@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: July 3, 2018
• Primary Completion: July 3, 2024
• Study Completion: January 3, 2025
• Last Updated: July 12, 2018

Record last verified: 2018-02

Locations

FR (1)