Long-term Prognosis for Non-functional Neuroendocrine Tumors of the Pancreatic Body and Tail ≤ 3cm

September 10, 2023 updated by: Xian-Jun Yu, Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Xianjun Yu, MD, PhD
        • Sub-Investigator:
          • Shunrong Ji, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parenchyma-sparing Resections
Parenchyma-sparing resections, including open, laparoscopic, or robotic pancreatic enucleation, duodenum-preserving pancreatic head resection, middle segment pancreatectomy, and spleen-preserving distal pancreatectomy, without standard lymph node dissection.
Other: Histopathological review, long-term prognosis and quality of life follow-up
Histopathological review, long-term prognosis and quality of life follow-up
Oncologic Resections
Oncologic resections, including open, laparoscopic, or robotic pancreaticoduodenectomy or distal pancreatectomy, with standard lymph node dissection.
Other: Histopathological review, long-term prognosis and quality of life follow-up
Histopathological review, long-term prognosis and quality of life follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Through study completion, an average of 1 year.
The time from the surgery to death from any cause.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complication rate
Time Frame: Within 90 days after surgery.
Adverse events that occur during or after the surgery, including the incidence of postoperative complications reported according to the Clavien-Dindo classification, clinical relevant postoperative pancreatic fistula (POPF), postoperative pancreatic hemorrhage (PPH), delayed gastric emptying (DGE), reoperation rate and mortality rate within 90 days after surgery.
Within 90 days after surgery.
Postoperative pathological staging
Time Frame: From the date of surgery to 1 month after surgery.
The tumor staging according to the 8th edition of the AJCC TNM staging system.
From the date of surgery to 1 month after surgery.
G staging
Time Frame: From the date of surgery to 1 month after surgery.
The G staging evaluated according to the 2019 WHO classification and grading criteria for digestive neuroendocrine tumors.
From the date of surgery to 1 month after surgery.
R0 resection rate
Time Frame: From the date of surgery to 1 month after surgery.
R0 margin rate on postoperative pathological assessment.
From the date of surgery to 1 month after surgery.
Lymph node positivity rate
Time Frame: From the date of surgery to 1 month after surgery.
Lymph node positivity rate on postoperative pathological assessment.
From the date of surgery to 1 month after surgery.
Life quality satisfaction evaluated according to a scale.
Time Frame: Through study completion, an average of 1 year.
The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Qilu Hospital of Shandong University
First Affiliated Hospital Xi'an Jiaotong University
Southern Medical University, China
The Third Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Xianjun Yu, MD, PhD, Fudan University
  • Study Director: Shunrong Ji, PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-NEN-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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