NCT03022188Active, not recruiting
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 · Last updated 21 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 10 Jan 2017
- Start date
- 10 Jan 2017
- Primary completion date
- 31 Jul 2022
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT03022188
What you commit to
- Study type: Observational
- Planned participants: 100
- From 10 Jan 2017 to the primary completion date, 31 Jul 2022
- 22 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 other malignant disease under treatment or with under 5 years remission, except in situ or intramucosal carcinoma.
Age
- Patients \< 18 years old
Other
- 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)
- Pregnant or breastfeeding women
- Patients judged not able to perform the monitoring
- Absence of signed consent for study enrolment
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Universitaire Saint Luc Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Hopital Sud Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHRU Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Hopital du Haut Leveque Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| Hopital Bocage central Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Centre Hospitalier Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Privé Jean Mermoz Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital Privé Européen Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Nord Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut Paoli-Calmette Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hopital de l'archet 2 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Clinique du Trocadero Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Européen George Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Robert Debré Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.