Removal of the primary small-intestine neuroendocrine tumor versus systemic therapy alone
Official title: 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)
Run by Insel Gruppe AG, University Hospital Bern · NCT06787014 · Data updated 2026-11-12
This project tries to see if removing the main small-intestine neuroendocrine tumor helps people with incurable metastatic disease live longer or avoid future problems, compared with treating them with systemic therapy alone.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 3200 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | March 9, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT06787014 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with small intestinal neuroendocrine tumors and non-curative metastatic disease who were asymptomatic for obstruction or bleeding and had a resectable primary tumor at diagnosis between 2005 and 2021.
✕Probably not a fit
Patients with high-grade (G3) tumors, those who had symptomatic obstruction or bleeding, those with unresectable primary tumors, or those with resectable metastatic disease are excluded and therefore not represented and may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Europe-wide, observational cohort uses patient records from 2005–2021 to compare outcomes in people with small intestinal neuroendocrine tumors (siNETs) and unresectable metastases who either had the primary tumor removed or received systemic treatment alone. The protocol excludes patients with high-grade (G3) tumors, resectable metastatic disease, non-resectable primaries, or initial symptoms of obstruction or bleeding to focus on asymptomatic, non-curative presentations. Investigators will perform histopathological review and use clinical variables such as liver tumor burden and mesenteric fibrosis to adjust for confounding when comparing survival, emergency complications, and later need for surgery. As a retrospective observational study, it can show associations that may inform practice but cannot definitively establish causation.
Why it matters
Potential benefit: If results show benefit, this work could clarify whether removing the primary tumor improves survival or prevents emergency complications for asymptomatic patients with metastatic siNETs, helping guide treatment choices.
How similar studies have gone: Prior retrospective studies have reported conflicting results and been limited by mixed patient groups and confounding, so a clear benefit of primary resection in this setting remains unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021 will be included. Exclusion Criteria: \- All patients with siNET G3, resectable metastatic 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.
Where it's running
-
UHI Berne
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Reto M. Kaderli — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Eliane Dohner
- Email: eliane.dohner@insel.ch
- Phone: 0041 31 664 28 31
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.