Pancreatic Tumor, Benign, Solid Pseudopapillary Tumor of the Pancreas
Conditions
Keywords
Pancreatic benign or low-grade malignant tumors, Parenchyma-sparing resection, Lymph node-sparing, lymph node dissection, Long-term prognosis
Brief summary
Solid pseudopapillary neoplasm (SPN) of the pancreas is a low-grade malignant tumor primarily treated with surgical resection. However, the oncologic safety of parenchyma-sparing resection (PSR) and the necessity of lymphadenectomy remain debated. This prospective cohort study evaluates these aspects based on long-term outcomes.
Detailed description
Solid pseudopapillary neoplasm (SPN) is a rare pancreatic tumor, accounting for approximately 1-3% of all pancreatic neoplasms, and predominantly affects young women . Although historically classified as a borderline lesion, SPN is currently regarded as a low-grade malignant neoplasm with an excellent long-term prognosis, with complete surgical resection achieving cure in 85-95% of patients. Even in the presence of recurrence or limited distant metastasis, aggressive surgical management can still result in prolonged survival. Given this indolent biological behavior and long life expectancy, the primary surgical challenge in SPN has gradually shifted from achieving oncologic radicality alone to balancing oncologic safety with long-term functional preservation. Parenchyma-sparing resection (PSR) has therefore gained increasing attention in the management of SPN. By preserving pancreatic parenchyma and avoiding complex gastrointestinal reconstruction, PSR has the potential to reduce surgical trauma and preserve long-term endocrine and exocrine function. However, concerns persist regarding its oncologic adequacy, particularly the risk of positive resection margins, limited lymph node assessment, and postoperative morbidity. Current evidence supporting PSR in SPN remains largely derived from small retrospective series, and robust data addressing long-term oncologic outcomes and functional consequences are lacking. Owing to the rarity and low malignant potential of SPN, prospective randomized trials comparing PSR with conventional oncologic resection (OR) are unlikely to be feasible. Consequently, optimal surgical strategy for SPN remains controversial. Using a large, prospectively maintained database, this study aimed to compare PSR and OR with respect to long-term oncologic outcomes, perioperative safety, and postoperative functional preservation. In addition, given the extremely low incidence of lymph node metastasis in SPN, we sought to further evaluate the necessity of routine lymph node dissection from a long-term outcome perspective.
Interventions
PROCEDUREParenchyma-sparing resection
PSR included enucleation (EN), duodenum-preserving pancreatic head resection (DPPHR), central pancreatectomy (CP), and spleen-preserving distal pancreatectomy (SPDP). OR included pancreatoduodenectomy (PD), distal pancreatectomy with splenectomy (DPS), and total pancreatectomy (TP).
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age between 18 and 75 years, regardless of gender; 2. patients with solid pseudopapillary neoplasm of the pancreas; 3. patients with an ECOG performance status of 0 or 1; 4. successfully received sugary (open or laparoscopic or robotic)
Exclusion criteria
(1) Pediatric patients with SPN under 14 years of age, or elderly patients over 80 years of age; (2) Reoperative resection for recurrent or metastatic SPN; (3) presence of distant metastasis or concomitant malignant tumors before surgery; and (4) loss to follow-up within 90 days after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | Within 90 days after surgery. | Reoperation rate within 90 days after surgery. |
| Rate of pancreatic enzyme-dependent malabsorption | Through study completion, an average of 3 year. | Postoperative pancreatic enzyme-dependent malabsorption rate. |
| Rate of new-onset diabetes | Through study completion, an average of 3 year. | Postoperative new-onset diabetes rate. |
| R0 resection rate | From the date of surgery to 1 month after surgery. | R0 margin rate on postoperative pathological assessment. |
| Recurrence-free survival (RFS) | Through study completion, an average of 3 year. | The time of surgery to the time of tumor recurrence or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Clinically Relevant Postoperative Pancreatic Fistula | Within 90 days after surgery. | Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas. |
| Perioperative complication rate according to the Clavien-Dindo classification | Within 90 days after surgery. | Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification. |
| Postoperative pancreatic hemorrhage (PPH) rate | Within 90 days after surgery. | Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition. |
| Delayed gastric emptying (DGE) rate | Within 90 days after surgery. | Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXianjun Yu, MD, PhD
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
STUDY_DIRECTORXiaowu Xu, MD, PhD
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
STUDY_CHAIRZheng Li, MD
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
Outcome results
None listed