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2023-05-01
2023-12-31
2023-12-31
800
NCT05907824
Fudan University
Fudan University
OBSERVATIONAL
Long-term Prognosis for Non-functional Neuroendocrine Tumors of the Pancreatic Body and Tail ≤ 3cm
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-05-29 | N/A | 2023-09-10 |
2023-06-08 | N/A | 2023-09-13 |
2023-06-18 | N/A | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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 dissecti | OTHER: 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from the surgery to death from any cause. | Through study completion, an average of 1 year. |
| Disease-free survival (DFS) | 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 | Measure Description | Time Frame |
|---|---|---|
| Perioperative complication rate | 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 | 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 | 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 | R0 margin rate on postoperative pathological assessment. | From the date of surgery to 1 month after surgery. |
| Lymph node positivity rate | 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. | 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xianjun Yu, MD, PhD Phone Number: +86-13801669875 Email: yuxianjun@fudanpci.org |
Study Contact Backup Name: Zheng Li, MD Phone Number: +86-18521097686 Email: lizheng@fudanpci.org |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
