Pancreatic Tumor, BenignPSR for SPNNCT07592663
Oncologic Safety and Lymphadenectomy in Parenchyma-Sparing Resection for SPN
An observational study of Pancreatic Tumor, Benign and Solid Pseudopapillary Tumor of the Pancreas, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Pancreatic Tumor, Benign, Solid Pseudopapillary Tumor of the Pancreas
- What is being tested?
- Parenchyma-sparing resection
- Type of treatment
- Surgery or procedure
- How many people
- 708 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2008to 1 Mar 2026
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients were eligible if they underwent surgical resection for pathologically confirmed SPN at the study center.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: 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.
Read the 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.
- Being tested
- Parenchyma-sparing resection
- Keywords
- Pancreatic benign or low-grade malignant tumors, Parenchyma-sparing resection, Lymph node-sparing, lymph node dissection, Long-term prognosis
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenchyma-sparing resectionProcedure or surgery
Also called oncologic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation rate
Reoperation rate within 90 days after surgery.
Measured: Within 90 days after surgery.
Rate of pancreatic enzyme-dependent malabsorption
Postoperative pancreatic enzyme-dependent malabsorption rate.
Measured: Through study completion, an average of 3 year.
Rate of new-onset diabetes
Postoperative new-onset diabetes rate.
Measured: Through study completion, an average of 3 year.
R0 resection rate
R0 margin rate on postoperative pathological assessment.
Measured: 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.
Measured: Through study completion, an average of 3 year.
Secondary outcomes (4)
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
Measured: Within 90 days after surgery.
Perioperative complication rate according to the Clavien-Dindo classification
Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification.
Measured: Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate
Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition.
Measured: Within 90 days after surgery.
Delayed gastric emptying (DGE) rate
Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition.
Measured: Within 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2008
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Tumor, BenignStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 708 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun Yu, MD, PhD, Principal investigator, Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, ChinaXiaowu Xu, MD, PhD, Study director, Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, ChinaZheng Li, MD, Study chair, Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592663
- Sponsor's protocol ID
- CSPAC-SPN-1
- Acronym
- PSR for SPN
- Status last verified
- Nov 2025
- First submitted
- 19 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35758433Liu 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.
PubMed 37036095Bersot 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.
PubMed 10064731Li 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.
PubMed 40381684
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenchyma-Sparing Resection for Pancreatic Solid Pseudopapillary Neoplasm: Oncologic Safety and Role of Lymphadenectomy in a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07592663
- Acronym / sponsor ID
- PSR for SPN / CSPAC-SPN-1
- Keywords
- Pancreatic benign or low-grade malignant tumors, Parenchyma-sparing resection, Lymph node-sparing, lymph node dissection, Long-term prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSR group | – | Procedure: Parenchyma-sparing resectionPatients 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). |
| 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). |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were eligible if they underwent surgical resection for pathologically confirmed SPN at the study center.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenchyma-sparing resectionAlso: oncologic resectionPSR 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). | Procedure or surgery | PSR group |
Primary outcome
Reoperation rate
Time frame: Within 90 days after surgery.
Reoperation rate 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.
Rate of new-onset diabetes
Time frame: Through study completion, an average of 3 year.
Postoperative new-onset diabetes rate.
R0 resection rate
Time frame: From the date of surgery to 1 month after surgery.
R0 margin rate on postoperative pathological assessment.
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.
4 secondary outcomes
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
Time frame: Within 90 days after surgery.
Perioperative complication rate according to the Clavien-Dindo classification
Time frame: Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate
Time frame: Within 90 days after surgery.
Delayed gastric emptying (DGE) rate
Time frame: Within 90 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication: PubMed 35758433Bolm 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.
- Results publication: PubMed 37036095Liu 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.
- Results publication: PubMed 10064731Bersot 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.
- Results publication: PubMed 40381684Li 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianjun Yu, MD, PhD principal investigator
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
Xiaowu Xu, MD, PhD study director
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
Zheng Li, MD study chair
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Tumor, Benign and Solid Pseudopapillary Tumor of the Pancreas, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation rate (time frame: Within 90 days after surgery.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07592663, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.