To hear about similar clinical trials, please enter your email below
Trial Title:
Long-term Prognosis for Non-functional Neuroendocrine Tumors of the Pancreatic Body and Tail ≤ 3cm
NCT ID:
NCT05907824
Condition:
Non Functioning Pancreatic Endocrine Tumor
Conditions: Official terms:
Neuroendocrine Tumors
Endocrine Gland Neoplasms
Pancreatic Neoplasms
Conditions: Keywords:
Non Functioning Pancreatic Endocrine Tumor
Body and Tail of the Pancreas
Parenchyma-sparing Resection
Oncologic Resection
Long-term Prognosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Histopathological review, long-term prognosis and quality of life follow-up
Description:
Histopathological review, long-term prognosis and quality of life follow-up
Arm group label:
Oncologic Resections
Arm group label:
Parenchyma-sparing Resections
Summary:
This study aims to quantify the malignant potential of non-functional neuroendocrine
tumors of the pancreatic body and tail ≤ 3 cm by collecting real-world data from large
pancreatic centers across the country, and to evaluate the appropriateness of
parenchyma-sparing resection and oncologic resection.
Detailed description:
According to epidemiological investigations, the incidence of neuroendocrine tumors has
increased 6.4-fold (6.98 per 100,000) . There is controversy in the latest guidelines
regarding the management of sporadic non-functional pancreatic neuroendocrine tumors
(pNETs) ≤ 2 cm, including follow-up and the choice between parenchyma-sparing resection
(PSR) and oncologic resection (OR) . Although pNETs are generally considered indolent
tumors, current experience suggests that 9.5%-12.3% of pNETs ≤ 2 cm may have lymph node
metastasis, and nearly 20% of resected tumors exhibit one or more invasive features.
Awareness of surgical treatment for these patients has been increasing gradually.
However, there is no clear recommendation for the choice of surgical approach, and if OR
is routinely performed, its prognostic value is unclear and there may be a risk of
overtreatment.
The advantages of PSR include preservation of both endocrine and exocrine pancreatic
function. However, the main oncological limitations of these techniques are inadequate
surgical margin clearance and the risk of lack of lymph node dissection. A recent
retrospective analysis of prospective databases from four large pancreatic surgery
centers showed that for ≤ 3 cm non-functional pNETs, PSR or lymph node-preserving
resection had less blood loss, shorter operation time, lower complications rate, and
similar long-term oncological outcomes compared to OR. However, this study did not
differentiate the tumor locations, as pNETs in the pancreatic head and body/tail have
different lymphatic drainage patterns and surgical approaches. Furthermore, the study
also showed significant differences in the proportion of PSR and the rate of positive
lymph nodes between tumors located in the pancreatic head and those in the body/tail.
The ability of existing literature to provide reliable guidelines for pNETs is limited by
the low incidence of the disease and short follow-up times. This study aims to quantify
the malignant potential of pNETs of the pancreatic body and tail ≤ 3 cm by collecting
real-world data from large pancreatic centers across the country, and to evaluate the
appropriateness of PSR and OR.
Criteria for eligibility:
Study pop:
Non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm.
Exclusion Criteria:
- Presence of liver or distant metastasis.
- Presence of concomitant malignancy.
- Multifocal or recurrent disease.
- Presence of hereditary syndrome (MEN1, VHL, NF).
- Presence of symptoms (specific symptoms of clinical syndromes suspected to be
related to excessive secretion of bioactive compounds).
- History of preoperative antitumor therapy.
- Loss to follow-up.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianjun Yu, MD, PhD
Phone:
+86-13801669875
Email:
yuxianjun@fudanpci.org
Investigator:
Last name:
Xianjun Yu, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Shunrong Ji, PhD
Email:
Sub-Investigator
Start date:
May 1, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
The Third Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Southern Medical University, China
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05907824
