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Clinical Trials/NCT05907824
NCT05907824RecruitingNot Applicable

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

Fudan University1 site in 1 country800 target enrollmentStarted: May 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
800
Locations
1
Primary Endpoint
Overall survival (OS)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Overall survival (OS)

Time Frame: Through study completion, an average of 1 year.

The time from the surgery to death from any cause.

Disease-free survival (DFS)

Time Frame: Through study completion, an average of 1 year.

The time of surgery to the time of tumor recurrence or death from any cause.

Secondary Outcomes

  • Perioperative complication rate(Within 90 days after surgery.)
  • Postoperative pathological staging(From the date of surgery to 1 month after surgery.)
  • Lymph node positivity rate(From the date of surgery to 1 month after surgery.)
  • G staging(From the date of surgery to 1 month after surgery.)
  • R0 resection rate(From the date of surgery to 1 month after surgery.)
  • Life quality satisfaction evaluated according to a scale.(Through study completion, an average of 1 year.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xian-Jun Yu

President of Fudan University Shanghai Cancer Center

Fudan University

Study Sites (1)

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