An observational study in Neuroendocrine Tumors, sponsored by Société Française d'Endoscopie Digestive. Active, not recruiting at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Société Française d'Endoscopie Digestive · Observational
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.
With increasing use of high-resolution conventional imaging, pancreatic incidentalomas are being diagnosed more frequently. In two recent surgical series, neuroendocrine tumors (NETs) and carcinomas account for 10-15 % of all pancreatic incidentalomas, the majority ( 75-90 % of cases) well differentiated. The factors affecting the behaviour of pancreatic NETs are differentiation, histological grade, staging, size and intratumoral microvascular density. In updated World Health Organization (WHO) classification, the grading system is based on tumor differentiation, the rate of proliferation and Ki-67 index. The management of pancreatic NETs depends on tumor stage and on presence or not of hormonal syndrome. By definition, the incidentally discovered pancreatic NETs (PNETs) are unassociated with hormonal syndromes (nonfunctioning) and detected in patients who undergo diagnostic evaluations for unrelated conditions.
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. There is a paucity of literature reporting pancreatic neuroendocrine incidentalomas and their characteristics. However, given their increased incidence, they are an emerging problem and require changes in treatment guidelines. 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. This therapeutic approach has two limitations: 1) the significant incidence of these tumors, because of the widespread use of routine imaging, and the improved technology of multi detector CT scan, the fortuitous discovery of small pancreatic incidentalomas is becoming more common. 2) Pancreatic surgery carries significant postoperative morbidity even in high-volume tertiary centers and even in parenchyma-preserving resection. This may results in many pancreatic resections for tumors with unknown natural history. On the other hand, the follow-up may be a factor of considerable anxiety, and carries the risk, actually difficult to assess, to let the tumor grow between two monitoring controls, with the possible evolution to the irreversible metastatic stage of the disease.
As a result, the investigators are unceasingly facing a dilemma: how to manage asymptomatic patients with small incidentally detected, potentially benign NETs? 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.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's planned enrollment of 100 is below the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Société Française d'Endoscopie Digestive is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with pancreatic tumors \<2cm (stage 1 discovered incidentally.
Exclusion Criteria:
Observational
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
Time frame: 36 months
progression rate among NF-PNEI ≤ 2cm in case of non-surgical management
- 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
Time frame: 36 months
determination of Ki67 value
determination of Ki67 value on cytological samples obtained by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) and on surgical specimen
Time frame: 36 months
performance of contrast harmonic endoscopic ultrasound (CH-EUS) for the diagnosis of malignancy
assessment of sensibility (Se), specificity (Spe), positive predictive value (PPV), negative predctive value (NPV) and accuracy of CH-EUS for the diagnosis of malignancy, appreciated by tumor microvascularisation assessment during CH-EUS procédures and correlation with tumor microvascular density appreciated on surgical specimen
Time frame: 36 months
rate of surgical treatment, delay from diagnosis to surgery and rationale
number of patients having undergone surgical treatment / total number of patients included in the study ; - number of days between diagnosis and surgical treatment ,
Time frame: 36 months
the rate of non-surgical management and the reasons that determined the choice of this therapeutic option
- number of patients with non- surgical management (monitoring) / total number of patients included in the study
Time frame: 36 months
to assess the morbidity among the patients with surgical treatment
-Morbidity defined as all complication occurring after surgical resection until discharge and/or readmission, and will be grade according to the Clavien-Dindo classification. Postoperative pancreatic fistula, haemorrhage, and delayed gastric emptying were defined according to the International Study Group of Pancreatic Surgery
Time frame: 36 months
to assess the mortality among the patients with surgical treatment
Perioperative mortality is death in relation to surgery, defined as death after surgical resection until discharge and/or readmission
Time frame: 36 monts
to assess the overall survival (OS) among the patients with surgical treatment
OS defined as the time from diagnosis to death of any cause
Time frame: 36 months
disease specific survival (DSS) among the patients with surgical treatment
DSS defined as the time from diagnosis to disease-related death and censored at the last follow-up date if no events had occurred.
Time frame: 36 months
to assess the progression-free survival (PFS) among the patients with surgical treatment
PFS is the period during and after treatment in which a participant is living with a disease that does not get worse defined and is defined as the time from diagnosis until 1) loco-regional or systemic recurrence, 2) second malignancy, or 3) death from any cause; late deaths not related to cancer or its treatment are excluded
Time frame: 36 months
to assess the morbidity among the patients with non-surgical treatment
morbidity defined as all complication occurred after endoscopic ultrasound procedures until discharge and/or readmission
Time frame: 36 months
to assess the mortality among the patients with non-surgical treatment
mortality defined as death in relation to endoscopic ultrasound procedure, occured until discharge and/or readmission
Time frame: 36 months
to assess the overal survival (OS) among the patients with non-surgical treatment
OS defined as the time from diagnosis to death of any cause
Time frame: 36 months
to assess the disease free survival (DSS) among the patients with non-surgical treatment
DSS defined as the time from diagnosis to disease-related death and censored at the last follow-up date if no events had occurred.
Time frame: 36 months
to assess the progression-free survival (PFS) among the patients with non-surgical treatment
PFS is the period during and after treatment in which a participant is living with a disease that does not get worse defined and is defined as the time from diagnosis until 1) loco-regional or systemic recurrence, 2) second malignancy, or 3) death from any cause; late deaths not related to cancer or its treatment are excluded
Time frame: 36 months
Quality of life assessment at baseline, 12, 24 and 36 months
The quality of life will be assessed using the 12-item Short-Form Health Survey (SF12) self- questionnaire
Time frame: baseline, 12, 24 and 36 months
Plan to share: No
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Société Française d'Endoscopie Digestive