Nonfunctioning Small (≤2 cm) Neuroendocrine Pancreatic Incidentaloma
1 other identifier
observational
100
2 countries
22
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2017
CompletedStudy Start
First participant enrolled
January 10, 2017
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 21, 2024
September 1, 2022
5.5 years
January 10, 2017
February 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of malignancy among nonfunctioning (NF) small (≤ 2 cm) pancreatic neuroendocrine incidentalomas (PNEI).
* 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
36 months
Secondary Outcomes (16)
progression rate among NF-PNEI ≤ 2cm in case of non-surgical management
36 months
determination of Ki67 value
36 months
performance of contrast harmonic endoscopic ultrasound (CH-EUS) for the diagnosis of malignancy
36 months
rate of surgical treatment, delay from diagnosis to surgery and rationale
36 months
the rate of non-surgical management and the reasons that determined the choice of this therapeutic option
36 months
- +11 more secondary outcomes
Study Arms (1)
Observational
Observational
Eligibility Criteria
Patient with pancreatic tumors \<2cm (stage 1 discovered incidentally.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Clinique Universitaire Saint Luc
Leuven, Belgium
Hopital Sud
Amiens, France
CHU Angers
Angers, France
CHRU Jean Minjoz
Besançon, France
Hopital du Haut Leveque
Bordeaux, France
Hopital Beaujon
Clichy, France
Hopital Bocage central
Dijon, France
Centre Hospitalier Lyon Sud
Lyon, France
Hopital Edouard Herriot
Lyon, France
Hopital Privé Jean Mermoz
Lyon, France
Hopital de la Timone
Marseille, France
Hopital Nord
Marseille, France
Hopital Privé Européen
Marseille, France
Hopital Saint Joseph
Marseille, France
Institut Paoli Calmette
Marseille, France
Hotel Dieu
Nantes, France
Hopital de l'archet 2
Nice, France
Clinique du Trocadero
Paris, France
Hopital Cochin
Paris, France
Hopital Européen George Pompidou
Paris, France
Hopital Robert Debré
Reims, France
CHU Rangueil
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodica Gincul, MD
Société Française d'Endoscopie Digestive
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Principal Investigator
Study Record Dates
First Submitted
January 10, 2017
First Posted
January 16, 2017
Study Start
January 10, 2017
Primary Completion
July 1, 2022
Study Completion (Estimated)
December 1, 2026
Last Updated
February 21, 2024
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share