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Trial record 71 of 739 for:    Recruiting, Not yet recruiting, Available Studies | Neuroendocrine tumors

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

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ClinicalTrials.gov Identifier: NCT03442959
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment
Small Intestinal Neuroendocrine Tumor Other: Data record

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Resection of the Primary Tumor vs no Resection in Asymptomatic Patients With Unresectable Synchronous Liver Metastases From siNEN
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 3, 2024
Estimated Study Completion Date : January 3, 2025

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Death [ Time Frame: 5 years ]
    Death due to Small Intestinal neuroendocrine Tumor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442959


Contacts
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Contact: Sophie DEGUELTE 03 26 83 27 78 ext 0033 sdeguelte@chu-reims.fr
Contact: Reza KIANMANESH rkianmanesh@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Sophie DEGUELTE    03 26 83 27 78    sdeguelte@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03442959     History of Changes
Other Study ID Numbers: PO17142
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Small intestine neuroendocrine tumor
palliative surgery
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue