Oncologic Safety and Lymphadenectomy in Parenchyma-Sparing Resection for SPN (PSR for SPN)

May 11, 2026 updated by: Xian-Jun Yu, Fudan University

Parenchyma-Sparing Resection for Pancreatic Solid Pseudopapillary Neoplasm: Oncologic Safety and Role of Lymphadenectomy in a Prospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

708

Contacts and Locations

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

Study Locations

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

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

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

Description

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.

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
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
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).
Other Names:
  • oncologic 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Recurrence-free survival (RFS)
Time Frame: Through study completion, an average of 3 year.
The time of surgery to the time of tumor recurrence or death.
Through study completion, an average of 3 year.
Reoperation rate
Time Frame: Within 90 days after surgery.
Reoperation rate within 90 days after surgery.
Within 90 days after surgery.
Rate of pancreatic enzyme-dependent malabsorption
Time Frame: Through study completion, an average of 3 year.
Postoperative pancreatic enzyme-dependent malabsorption rate.
Through study completion, an average of 3 year.
Rate of new-onset diabetes
Time Frame: Through study completion, an average of 3 year.
Postoperative new-onset diabetes rate.
Through study completion, an average of 3 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
Time Frame: 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.
Within 90 days after surgery.
Perioperative complication rate according to the Clavien-Dindo classification
Time Frame: Within 90 days after surgery.
Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification.
Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate
Time Frame: Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition.
Within 90 days after surgery.
Delayed gastric emptying (DGE) rate
Time Frame: Within 90 days after surgery.
Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition.
Within 90 days after surgery.

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xianjun Yu, MD, PhD, Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
  • Study Director: Xiaowu Xu, MD, PhD, Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
  • Study Chair: Zheng Li, MD, Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China

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

Helpful Links

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)

July 1, 2008

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-SPN-1

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.

Clinical Trials on Solid Pseudopapillary Tumor of the Pancreas

Clinical Trials on Parenchyma-sparing resection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe