Clinical trial · Observational
Nonfunctioning Small (≤2 cm) Neuroendocrine Pancreatic Incidentaloma
Nonfunctioning Small (≤2 cm) Neuroendocrine Pancreatic Incidentaloma: Clinical and Morphological Findings, and Therapeutic Options (IPANEMA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Observational
Primary outcomes (1)
- measure
- rate of malignancy among nonfunctioning (NF) small (≤ 2 cm) pancreatic neuroendocrine incidentalomas (PNEI).
- timeFrame
- 36 months
- description
- * any G3 tumor \* * G2 \* or G1 \* tumor with lymph node metastases and / or distant metastasis * G2 or G1 tumor with recurrence during the clinical and morphological surveillance after surgical treatment
Secondary outcomes (16)
- measure
- progression rate among NF-PNEI ≤ 2cm in case of non-surgical management
- timeFrame
- 36 months
- description
- \- significant increase of tumor size within one year \> 20% on radiological examination or \> 2 mm at endoscopic ultrasound ; - appearance of metastatic lymph nodes and / or distant metastases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients older than 18 years old * with a small size ≤ 2 cm (stage I) non-functioning pancreatic neuroendocrine incidentaloma, cytologically and/or histologically proved or, in case of impossibility to obtain a cyto-histological specimen, with highly suggested diagnosis by imaging (early, homogenous enhancement at computerized tomography (CT- scan) and/or magnetic resonance Imaging (MR)I and positivity at somatostatin receptor scintigraphy (SRS)) * patient ASA 1-2 (assessed according to ASA physical status classification system of American Society of Anesthesiology) * after geriatric evaluation for the patients older than 75 y.o * affiliated to a social security system * with signed consent for study enrolment. Exclusion Criteria: * Patients \< 18 years old * Patients with NET with size \> 2 cm ( stage II-IV) or NEC and/or with presence of signs suspicious of malignancy * Patients with a functioning NET or NEC (clinical syndrome caused by excess hormonal secretion, as insulinoma or Zollinger -Ellison syndrome) * Patients with multiple pancreatic neuroendocrine tumors * Patients with multiple endocrine neoplasia type 1 (MEN1) * Patients with suspicion of non- neuroendocrine tumor * Patient ASA 3-4 (assessed according to ASA physical status classification system of American Society of Anesthesiology) * Patients with other malignant disease under treatment or with under 5 years remission, except in situ or intramucosal carcinoma. * Pregnant or breastfeeding women * Patients judged not able to perform the monitoring * Absence of signed consent for study enrolment
References
Publications (0)
Data not yet available