An observational study in Neuroendocrine (NE) Tumors, Metastasis and Bowel Obstruction, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 3,200 is above the median of 136 across 557 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Compared within Neoplasm Metastasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The investigators will include all patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- All patients with siNET and non-curative disease between 01.01.2005 and 31.12.2021 will be included.
Exclusion Criteria:
- All patients with siNET G3, resectable disease and/or non-resectable primary tumor at initial diagnosis will be excluded. Furthermore, symptomatic patients (small intestinal obstruction, bleeding) or when imaging suggests that obstruction will probably occur (bowel dilatation, mesenteric fibrosis) at initial diagnosis will be excluded. Patients with diarrhea, flushing, or abdominal pain will not be excluded.
Patients with a documented rejection for a further use of their data for scientific purposes will also be excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients will be grouped according to whether a primary tumor resection within 6 months after initial diagnosis was performed (yes vs. no).
Other: Histopathological review
Histopathological review
To evaluate the 10-year overall survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
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 evaluate the progression-free survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
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 examine the risk of small intestinal obstruction with or without palliative primary tumor resection
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
To examine the risk of small intestinal hypoperfusion with or without palliative primary tumor resection
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
To evaluate the morbidity of palliative primary tumor resection
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
To evaluate the mortality of palliative primary tumor resection
To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.
Time frame: 10 years follow-up
To assess prognostic factors for long-term survival
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.
Time frame: 10 years follow-up
Plan to share: No
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Insel Gruppe AG, University Hospital Bern →