Clinical trial NCT05907824: Long-term Prognosis for Non-functional Neuroendocrine Tumors of the Pancreatic Body and Tail ≤ 3cm
Official title: Long-term Prognosis Comparison Between Parenchyma-sparing and Oncologic Resections for Non-functional Neuroendocrine Tumors of the Pancreatic Body and Tail ≤ 3cm: a Real-world Data Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Functioning Pancreatic Endocrine Tumor
Keywords: Non Functioning Pancreatic Endocrine Tumor
Body and Tail of the Pancreas
Parenchyma-sparing Resection
Oncologic Resection
Long-term Prognosis
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Soochow University
name: Qilu Hospital of Shandong University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Southern Medical University, China
First posted: 2023-06-18
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 1 year.
measure: Disease-free survival (DFS)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Perioperative complication rate
timeFrame: Within 90 days after surgery.
measure: Postoperative pathological staging
timeFrame: From the date of surgery to 1 month after surgery.
measure: G staging
timeFrame: From the date of surgery to 1 month after surgery.
measure: R0 resection rate
timeFrame: From the date of surgery to 1 month after surgery.
measure: Lymph node positivity rate
timeFrame: From the date of surgery to 1 month after surgery.
measure: Life quality satisfaction evaluated according to a scale.
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xianjun Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Shunrong Ji, PhD
role: STUDY_DIRECTOR
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