A conservative approach, rather than surgical resection, is safe for non-functioning grade 1 and 2 pancreatic neuroendocrine tumors
ID
Bron
Verkorte titel
Aandoening
Pancreatic neuroendocrine tumors
Neuroendocriene tumoren van de alvleesklier
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Tumor progression
Achtergrond van het onderzoek
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.
Doel van het onderzoek
A conservative approach, rather than surgical resection, is safe for non-functioning grade 1 and 2 pancreatic neuroendocrine tumors <2cm.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
No interventions, since patients will be treated according to the international 2016 ENETS guidelines.
Publiek
E.J.M Nieveen van Dijkum
Amsterdam
The Netherlands
e.j.nieveenvandijkum@amc.nl
Wetenschappelijk
E.J.M Nieveen van Dijkum
Amsterdam
The Netherlands
e.j.nieveenvandijkum@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Hereditary syndromes
- Functioning pNET (insulinoma, gastrinoma etc)
- pNET grade 3 according to 2010/2017 WHO grading system
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6510 |
NTR-old | NTR6698 |
Ander register | AMC ziekenhuis : W16_242 # 16.283 |