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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
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

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinique Universitaire Saint Luc
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LeuvenBelgiumUnknown status
Hopital Sud
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AmiensFranceUnknown status
CHU Angers
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AngersFranceUnknown status
CHRU Jean Minjoz
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BesançonFranceUnknown status
Hopital du Haut Leveque
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BordeauxFranceUnknown status
Hopital Beaujon
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ClichyFranceUnknown status
Hopital Bocage central
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DijonFranceUnknown status
Centre Hospitalier Lyon Sud
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LyonFranceUnknown status
Hopital Edouard Herriot
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LyonFranceUnknown status
Hôpital Privé Jean Mermoz
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LyonFranceUnknown status
Hopital Privé Européen
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MarseilleFranceUnknown status
Hopital de la Timone
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MarseilleFranceUnknown status
Hôpital Saint Joseph
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MarseilleFranceUnknown status
Hôpital Nord
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MarseilleFranceUnknown status
Institut Paoli-Calmette
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MarseilleFranceUnknown status
Hotel Dieu
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NantesFranceUnknown status
Hopital de l'archet 2
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NiceFranceUnknown status
Clinique du Trocadero
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ParisFranceUnknown status
Hopital Européen George Pompidou
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ParisFranceUnknown status
Hôpital Cochin
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ParisFranceUnknown status
Hopital Robert Debré
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ReimsFranceUnknown status
CHU Rangueil
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ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.