search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Small pancreatic neuroendocrine tumors


- candidate number27825
- NTR NumberNTR6698
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2017
- Secondary IDsW16_242 # 16.283 AMC ziekenhuis
- Public TitleSmall pancreatic neuroendocrine tumors
- Scientific TitleProspective nationwide observational cohort of patient with pancreatic neuroendocrine tumors <2cm.
- ACRONYMPANDORA
- hypothesisA conservative approach, rather than surgical resection, is safe for non-functioning grade 1 and 2 pancreatic neuroendocrine tumors <2cm.
- Healt Condition(s) or Problem(s) studiedNeuroendocrine tumors, Pancreas
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2017
- planned closingdate31-dec-2027
- Target number of participants100
- InterventionsNo interventions, since patients will be treated according to the international 2016 ENETS guidelines.
- Primary outcomeTumor progression
- Secondary outcomeSurgical resection rate
Reasons to resect
Quality of Life
Survival
- TimepointsWait-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
- Trial web sitewww.amc.nl/pandora
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E.J.M Nieveen van Dijkum
- CONTACT for SCIENTIFIC QUERIES E.J.M Nieveen van Dijkum
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Non-restricted fund
- Publications
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD6-sep-2017 - 30-sep-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl