UHI Berne
Bern, 3010, Switzerland
Location status: Recruiting
NCT Number: NCT06787014
When possible, surgery to completely remove small intestinal neuroendocrine tumors (siNETs) is always recommended. However, in cases where the tumor has spread and cannot be cured completely, it is unclear whether a surgical removal of the primary tumor only is reasonable. In this situation, current guidelines from the European Neuroendocrine Tumor Society (ENETS) recommend surgery only for patients who have symptoms like intestinal blockage or bleeding, or are at risk of such complications. For patients without symptoms, it is still unclear whether removing the main tumor improves overall outcomes and prevents future problems.
Studies evaluating this type of surgery on survival show conflicting results. These studies often do not separate patients with symptoms from those without, and they overlook other important factors like the amount of cancer in the liver and nearby tissues. Due to these uncertainties, the rarity of siNETs and many factors that can affect outcomes, like age, overall health, or other current treatments, conducting a high-quality study to answer this question is challenging. To address this, the present Europe-wide study is being planned.
This study aims to determine if resecting the main tumor improves the 10-year overall survival and reduces risks like intestinal blockages or blood flow issues compared to no surgery in patients without symptoms. The study will also assess other outcomes, such as how long patients stay free from disease progression, the risks of surgery, and prognostic factors for long-term survival. This international collaboration among neuroendocrine tumor referral centers will provide robust evidence to guide clinical practice and update treatment guidelines for siNETs.
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Observational
Bern, 3010, Switzerland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with a documented rejection for a further use of their data for scientific purposes will also be excluded.
Histopathological review
Time frame: 10 years follow-up
For the survival analysis, Kaplan-Meier method will be used to estimate overall survival at 10 years for patients with and without primary tumor resection.
Time frame: 10 years follow-up
For the survival analysis, Kaplan-Meier method will be used to estimate overall survival at 10 years for patients with and without primary tumor resection.
Time frame: 10 years follow-up
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
The following prognostic information will be taken into account: age, sex, ECOG, presence of second malignancy, and adjusted for characteristics of the siNET (Ki-67 index, number of siNETs, lymph node metastases, TBS, extrahepatic metastases, CgA level, 5-HIAA level, carcinoid heart disease, and use of other treatments), with results presented as adjusted hazard ratios (HRs) and 95% CI.
Contact information is provided by the study sponsor or research team.
Insel Gruppe AG, University Hospital Bern
Other
Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Retrospective, Europe-wide, Pooled Cohort Study (ENETS-SurgSmInt)
Acronym: ENETSSurgSmInt
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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