Multicentric Database for Solid Pseudopapillary Neoplasm of the Pancreas

NCT ID: NCT07183280

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2041-12-30

Brief Summary

To establish and maintain a reliable multicenter real-world database for pancreatic SPN, providing high-quality data and evidence-based support for clinical/translational research.

Detailed Description

Pancreatic solid pseudopapillary neoplasm (SPN) is a low-grade malignant tumor, accounting for 0.2%-2.7% of pancreatic tumors, with unique histological and biological characteristics. Its pathological features include solid-cystic and pseudopapillary structures. SPN occurs predominantly in younger individuals, with a median age of 27-31 years. Male patients tend to be older than female patients, but the incidence is significantly higher in females. This gender disparity may be related to hormonal factors or genetic susceptibility. Although most patients have excellent prognosis (10-year survival rate >95%), approximately 10% may develop metastasis or recurrence, particularly in cases with high-risk pathological features. Reported incidence rates are higher in Asia than in Western countries, with Chinese multicenter studies indicating SPN constitutes 2.8% of pancreatic tumors. SPN exhibits significant differences from other pancreatic tumors in epidemiology, morphology, immunophenotype, and genetics, warranting classification as a distinct pathological entity for clinical management and prognostic evaluation.

Real-world study (RWS) refers to the systematic collection of patient health data in real-world clinical settings [real-world data (RWD)] to address predefined medical questions, employing multidisciplinary methods for comprehensive analysis to generate real-world evidence (RWE). RWS can inform clinical decision-making, support drug development and regulatory decisions, and guide public health policies through pharmacoeconomic evaluations. As an important complement and extension to randomized controlled trials (RCTs), RWS has gained increasing attention globally in recent years. In May 2019, the U.S. FDA issued draft guidance on "Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics", detailing the use of RWD/RWE for regulatory approvals. China's NMPA released the "Guideline for Real-World Evidence to Support Drug Development and Evaluation (Trial)" in January 2020, formally incorporating RWE into drug development and regulatory frameworks. Similar initiatives exist in Japan, South Korea, and the EU. As of June 2020, over 2,000 RWS studies were registered globally, including 300+ in China (70+ related to oncology).

SPN is insensitive to chemotherapy and radiotherapy, with complete surgical resection being the cornerstone of cure. R0 resection (negative margins) reduces recurrence and improves survival. For resectable SPN, surgery is strongly recommended. Despite being classified as malignant, SPN exhibits indolent growth with excellent outcomes. Most patients undergoing R0 resection achieve cure. Organ-preserving techniques (e.g., enucleation, spleen-preserving distal pancreatectomy) and minimally invasive approaches (laparoscopic/robotic) are prioritized to reduce complications and enhance quality of life. However, large-scale evidence comparing surgical approaches (minimally invasive vs. open; standard vs. limited resection) remains limited.

Given SPN's rarity and slow research progress, the investigators propose establishing a multicenter RWS database to:

1. Design a tailored database system for SPN, retrospectively collecting clinical data from Shanghai Pancreatic Tumor Institute and other centers;

2. Prospectively collect and maintain SPN patient data to support clinical and translational research.

Conditions

Solid Pseudopapillary Neoplasm of the Pancreas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

operation

Enucleation, spleen-preserving distal pancreatectomy, or duodenum-preserving pancreatic head resection, etc

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• No restrictions on age, gender, or performance status;
• Pathologically/cytologically confirmed SPN;
• Compliance with follow-up requirements;

Exclusion Criteria

• Non-neoplastic pancreatic lesions;
• Non-pancreatic primary tumors;
• Non-compliance with follow-up;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Guopei Luo

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guopei Luo

Role: PRINCIPAL_INVESTIGATOR

Shanghai Cancer Center

Locations

Shanghai Cancer Center

Shanghai, Special Administrative Region, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huanyu Xia, MD

Role: CONTACT

xiahuanyu@fudanpci.org

+86 2164175590 ext. 1307

Guopei Luo, MD

Role: CONTACT

luoguopei@hotmail.com

86-21-64175590 ext. 1307

Facility Contacts

Guopei Luo

Role: primary

luoguopei@hotmail.com

+86868621641755

References

Hua Y, Hong X, Dai M, Li J, Yang S, Guo J, Wang W, Xu Q, Han X, Wang M, Huang N, Zheng H, Kleeff J, Liu Q, Wu W, Zhang T, Liao Q, Zhao Y. Local resection for solid pseudopapillary neoplasms of the pancreas shows improved postoperative gastrointestinal function and reduced mental stress: a multiquestionnaire survey from a large cohort. Int J Surg. 2023 Dec 1;109(12):3815-3826. doi: 10.1097/JS9.0000000000000702.

Reference Type: BACKGROUND

PMID: 37830944 (View on PubMed)

Other Identifiers

PTCA199-15

Identifier Type: -

Identifier Source: org_study_id