Neuroendocrine (NE) TumorsENETSSurgSmIntNCT06787014
Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study
An observational study of Neuroendocrine (NE) Tumors and Metastasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroendocrine (NE) Tumors, Metastasis, Bowel Obstruction
- What is being tested?
- Histopathological review
- How many people
- 3,200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Mar 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators will include all patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021.
Who may be able to join
- All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021 will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
- Conditions
- Neuroendocrine (NE) Tumors, Metastasis, Bowel Obstruction
- Being tested
- Histopathological review
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histopathological reviewOther
Histopathological review
| Study group | Role | What they receive |
|---|---|---|
| Histopathological review | The patients will be grouped according to whether a primary tumor resection within 6 months after initial diagnosis was performed (yes vs. no). Receives: Other: Histopathological review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years follow-up
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start9 Mar 2026
- Primary completion9 Mar 2026
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine (NE) TumorsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reto M. Kaderli, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787014
- Sponsor's protocol ID
- ENETSSurgSmInt
- Acronym
- ENETSSurgSmInt
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06787014
- Acronym / sponsor ID
- ENETSSurgSmInt / ENETSSurgSmInt
- Conditions
- Neuroendocrine (NE) Tumors, Metastasis, Bowel Obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histopathological review | – | Other: Histopathological reviewThe patients will be grouped according to whether a primary tumor resection within 6 months after initial diagnosis was performed (yes vs. no). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators will include all patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021.
Key inclusion criteria (1 listed)
- All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021 will be included.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histopathological reviewHistopathological review | Other | Histopathological review |
Primary outcome
To evaluate the 10-year overall survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
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.
6 secondary outcomes
To evaluate the progression-free survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
Time frame: 10 years follow-up
To examine the risk of small intestinal obstruction with or without palliative primary tumor resection
Time frame: 10 years follow-up
To examine the risk of small intestinal hypoperfusion with or without palliative primary tumor resection
Time frame: 10 years follow-up
To evaluate the morbidity of palliative primary tumor resection
Time frame: 10 years follow-up
To evaluate the mortality of palliative primary tumor resection
Time frame: 10 years follow-up
To assess prognostic factors for long-term survival
Time frame: 10 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reto M. Kaderli principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine (NE) Tumors and Metastasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliane Dohner (0041 31 664 28 31, eliane.dohner@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the 10-year overall survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients. (time frame: 10 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.