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Nonfunctioning Small (≤2 cm) Neuroendocrine Pancreatic Incidentaloma

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study completion date: Dec 2022 to Dec 2026v6
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jan 2022 to Jul 2022
    • Study completion date: Jan 2022 to Dec 2022
    • Site details revised at 22 of 22 sites
    v5
  3. Notable Primary completion date: Jan 2019 to Jan 2022v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 22
    • Start date: Jan 2017 to Jan 10, 2017
    v3
  5. Minor Eligibility criteria expanded, about 35 words
    • Secondary endpoints revised (16)
    • Study description expanded, about 3 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neuroendocrine tumors (NETs) and carcinomas account for 10-15 % of all pancreatic incidentalomas. The management of pancreatic NETs depends on tumor stage and on presence or not of hormonal syndrome. The therapeutic approach for hormonally functional tumor, or large tumor (\> 2 cm) with local, vascular or lymph nodes invasion, highly suggestive of malignancy, or in presence of metastasis, is well admitted: surgery is indicated or should be discussed. However, the attitude is less consensual for small (≤ 2 cm) non-functioning (NF) and non-metastatic lesions. In English, American or French recommendations, systematic surgical resection with lymphadenectomy is currently recommended in all medically fit patients. The follow-up (FU) is possible for tumors \<2 cm (T1) located in the pancreatic head and for which enucleation is not feasible. Several recently published retrospective studies discuss the "non- surgical" management of the small NF incidentally detected pancreatic NETs (IPNETs) and highlight the necessity of developing guidelines for management of these patients. A strict correlation between tumor size and malignancy of these tumors was demonstrated in the single-center retrospective Italian study of Bettini and col., which included all patients with NF PNETs who underwent curative (R0) resection during 18 years. In the group of 51 patients with small size of T (2 cm or less), incidentally discovered, the majority of lesion was benign, and the authors concluded that follow-up can be proposed in patients with incidentally discovered NF PNETs ≤ 2 cm. However in despite of small size and asymptomatic character of the tumor, the rate of malignancy of NF IPNETs ≤ 2 cm was estimated to be 24 % (in 18% and 6% of cases, uncertain behaviour and carcinoma were present). Given the inherent morbidities associated with pancreatic surgery, a risk-benefit calculation may favour surveillance rather than surgery in highly selected patients. Thus, a better understanding of NF IPNETs and identification of their prognostic factors can be of help to select a subgroup of patients who could benefit from a long-term surveillance rather than a systematic surgical resection. Clearly, large prospective trials are needed to validate this approach.
Trial Details
NCT Number NCT03022188
Lead Sponsor Société Française d'Endoscopie Digestive
Conditions
(from sponsor)
Neuroendocrine Tumors
Related terms Adenoma, Islet Cell, Neuroendocrine Tumors
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov