NCT07592663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
17.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

November 1, 2025

Enrollment Period

17.7 years

First QC Date

March 19, 2026

Last Update Submit

May 11, 2026

Conditions

Pancreatic Tumor, BenignSolid Pseudopapillary Tumor of the Pancreas

Keywords

Pancreatic benign or low-grade malignant tumorsParenchyma-sparing resectionLymph node-sparinglymph node dissectionLong-term prognosis

Outcome Measures

Primary Outcomes (5)

  • Reoperation rate

    Reoperation rate within 90 days after surgery.

    Within 90 days after surgery.

  • Rate of pancreatic enzyme-dependent malabsorption

    Postoperative pancreatic enzyme-dependent malabsorption rate.

    Through study completion, an average of 3 year.

  • Rate of new-onset diabetes

    Postoperative new-onset diabetes rate.

    Through study completion, an average of 3 year.

  • R0 resection rate

    R0 margin rate on postoperative pathological assessment.

    From the date of surgery to 1 month after surgery.

  • Recurrence-free survival (RFS)

    The time of surgery to the time of tumor recurrence or death.

    Through study completion, an average of 3 year.

Secondary Outcomes (4)

  • Incidence of Clinically Relevant Postoperative Pancreatic Fistula

    Within 90 days after surgery.

  • Perioperative complication rate according to the Clavien-Dindo classification

    Within 90 days after surgery.

  • Postoperative pancreatic hemorrhage (PPH) rate

    Within 90 days after surgery.

  • Delayed gastric emptying (DGE) rate

    Within 90 days after surgery.

Study Arms (2)

PSR group

Patients with solid pseudopapillary neoplasm who underwent parenchyma-sparing resection (PSR). PSR included enucleation (EN), duodenum-preserving pancreatic head resection (DPPHR), central pancreatectomy (CP), and spleen-preserving distal pancreatectomy (SPDP).

Procedure: Parenchyma-sparing resection

OR group

Patients with solid pseudopapillary neoplasm who underwent oncologic resection (OR). OR included pancreatoduodenectomy (PD), distal pancreatectomy with splenectomy (DPS), and total pancreatectomy (TP).

Interventions

Parenchyma-sparing resectionPROCEDURE

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).

Also known as: oncologic resection
PSR group

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were eligible if they underwent surgical resection for pathologically confirmed SPN at the study center.

You may qualify if:

  • age between 18 and 75 years, regardless of gender;
  • patients with solid pseudopapillary neoplasm of the pancreas;
  • patients with an ECOG performance status of 0 or 1;
  • successfully received sugary (open or laparoscopic or robotic)

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (4)

  • Bolm L, Nebbia M, Wei AC, Zureikat AH, Fernandez-Del Castillo C, Zheng J, Pulvirenti A, Javed AA, Sekigami Y, Petruch N, Qadan M, Lillemoe KD, He J, Ferrone CR; PAncreatic Neuroendocrine Disease Alliance (PANDA). Long-term Outcomes of Parenchyma-sparing and Oncologic Resections in Patients With Nonfunctional Pancreatic Neuroendocrine Tumors <3 cm in a Large Multicenter Cohort. Ann Surg. 2022 Sep 1;276(3):522-531. doi: 10.1097/SLA.0000000000005559. Epub 2022 Jun 27.

    PMID: 35758433RESULT

  • Liu Q, Dai M, Guo J, Wu H, Wang W, Chen G, Hu Y, Han X, Xu Q, Zhang X, Yang S, Zhang Y, Kleeff J, Liao Q, Wu W, Liang Z, Zhang T, Zhao Y. Long-term Survival, Quality of Life, and Molecular Features of the Patients With Solid Pseudopapillary Neoplasm of the Pancreas: A Retrospective Study of 454 Cases. Ann Surg. 2023 Dec 1;278(6):1009-1017. doi: 10.1097/SLA.0000000000005842. Epub 2023 Apr 10.

    PMID: 37036095RESULT

  • Bersot TP, Vega GL, Grundy SM, Palaoglu KE, Atagunduz P, Ozbayrakci S, Gokdemir O, Mahley RW. Elevated hepatic lipase activity and low levels of high density lipoprotein in a normotriglyceridemic, nonobese Turkish population. J Lipid Res. 1999 Mar;40(3):432-8.

    PMID: 10064731RESULT

  • Li J, Zheng H, Zhang X, Pan B, Lu J, Zhou L, Zhang T, Dai M, Guo J, Wang W, Han X, Xu Q, Hua Y, Kleeff J, Wu H, Liang Z, Liu Q, Liao Q. Molecular profiling reveals the malignant potential in solid pseudopapillary neoplasms of the pancreas. Cancer Lett. 2025 Aug 10;625:217788. doi: 10.1016/j.canlet.2025.217788. Epub 2025 May 15.

    PMID: 40381684RESULT

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Xianjun Yu, MD, PhD

    Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China

    PRINCIPAL INVESTIGATOR

  • Xiaowu Xu, MD, PhD

    Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China

    STUDY DIRECTOR

  • Zheng Li, MD

    Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Fudan University Shanghai Cancer Center

Study Record Dates

First Submitted

March 19, 2026

First Posted

May 18, 2026

Study Start

July 1, 2008

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 18, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)