Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study

NCT06787014 | Recruiting

• 1 other identifier: ENETSSurgSmInt
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  10 years follow-up

• To examine the risk of small intestinal obstruction with or without palliative primary tumor resection

  10 years follow-up

• To examine the risk of small intestinal hypoperfusion with or without palliative primary tumor resection

  10 years follow-up

• To evaluate the morbidity of palliative primary tumor resection

  10 years follow-up

• To evaluate the mortality of palliative primary tumor resection

  10 years follow-up

Study Arms (1)

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).

Other: Histopathological review

Interventions

Histopathological review OTHER

Histopathological review

Histopathological review

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will include all patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021.

You may qualify if:

• \- All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021 will be included.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

UHI Berne

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Reto M. Kaderli

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliane Dohner

CONTACT

0041 31 664 28 31; eliane.dohner@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 22, 2025
• Study Start: March 9, 2026
• Primary Completion: March 9, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)