No registrations found.
ID
Source
Brief title
Health condition
Pancreatic neuroendocrine tumors
Neuroendocriene tumoren van de alvleesklier
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tumor progression
Secondary outcome
Surgical resection rate
Reasons to resect
Quality of Life
Survival
Background summary
Rationale: pancreatic neuroendocrine tumors (pNET) are more often diagnosed incidentally due to the use of better imaging techniques. Surgical resection is the only curative treatment and long term follow-up indicates a survival benefit for patients who underwent primary resection. However, pancreatic resections are associated with serious postoperative morbidity. In addition, recent literature shows that incidentally found pNET have a significant smaller size and are more commonly associated with lower tumor stages. Progression or tumor growth in small incidentally found non-functioning pNET seems minimal. Therefore, the European Neuroendocrine Tumor Society (ENETS) has updated their guidelines; surveillance is now recommended for patients with non-functional pNET <2cm. Although this approach seems safe, long term follow-up data are needed to guarantee the safety of this policy.
Objective: To monitor long term effects of a non-operative management of small pNETs.
Study design: A prospective, multicentre, cohort in collaboration with all Dutch Pancreatic Cancer Group (DPCG) affiliated centers that treat patients with pNET.
Study population: patients diagnosed with a pNET <2cm.
Endpoints: Tumor progression and survival will be the primary outcomes. In addition, patients who do undergo a resection despite the guideline will be observed. The reasons to deviate from the initial therapy will be investigated. A secondary outcome will be the quality of life of all patients that are diagnosed with a pNET <2cm, regardless of received therapy.
Study objective
A conservative approach, rather than surgical resection, is safe for non-functioning grade 1 and 2 pancreatic neuroendocrine tumors <2cm.
Study design
Wait-and-see protocol
- year 1: 3, 6, 9, 12 months
- year 2: 18, 24 months
- year 3: 30 36 months
- year 3-10: every 12 months
After surgical resection:
- year 1: 6 and 12 months
- year 2-5: every 12 months
Intervention
No interventions, since patients will be treated according to the international 2016 ENETS guidelines.
E.J.M Nieveen van Dijkum
Amsterdam
The Netherlands
e.j.nieveenvandijkum@amc.nl
E.J.M Nieveen van Dijkum
Amsterdam
The Netherlands
e.j.nieveenvandijkum@amc.nl
Inclusion criteria
- Diagnosed with pancreatic NET on at least 2 imaging modalities (pathology is not necessary, only in doubt)
- No distant metastases
- Patients >18 years
- Able to read and write in Dutch/English
Exclusion criteria
- Hereditary syndromes
- Functioning pNET (insulinoma, gastrinoma etc)
- pNET grade 3 according to 2010/2017 WHO grading system
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6510 |
| NTR-old | NTR6698 |
| Other | AMC ziekenhuis : W16_242 # 16.283 |