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Cross-sectional Follow-up on Digestive and Social Functions of SPN

An Observational Cross-sectional Follow-up Study on Digestive Physiological and Social Philosophical Functions of Solid Pseudopapillary Neoplasm of the Pancreas (SPN)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05604716
Enrollment
300
Registered
2022-11-03
Start date
2001-01-01
Completion date
2026-08-01
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer, Solid Pseudopapillary Tumor of the Pancreas

Keywords

Solid Pseudopapillary Neoplasm of the Pancreas, surgery, follow up, digestive physiological function, social psychological function

Brief summary

An observational cross-sectional follow-up study on the quality of life (two aspects, digestive physiological and social psychological functions) of solid pseudopapillary neoplasm of the pancreas (SPN) patients recruited in PUMCH from 2001 to 2026. The quality of life is evaluated by a questionnaire made up of eight validated scales.

Detailed description

Solid pseudopapillary neoplasm of the pancreas (SPN) is a rare tumor with uncertain malignant potential. It is a rare entity of pancreatic tumor with low potential malignancy, constituting 1% to 3% of pancreatic tumors and 10%-15% of pancreatic cystic neoplasm. Although the reported cases of SPN have been increasing rapidly all over the world during the last two decades, its long-term follow-up studies in large cohorts remain missing. From this, this observational cross-sectional follow-up study on the digestive physiological and social psychological functions of SPN patients aims to achieve a comprehensive understanding on how SPN and surgery affects the quality of life. Patients are recruited in PUMCH from 2001-2026 with a definite pathological diagnosis. The quality of life after surgery is evaluated by a questionnaire made up of six validated scales (digestive physiological functions via: 8 symptoms scale of the EORTC core quality of life questionnaire (EORTC QLQ-C30); gastrointestinal symptom rating scale questionnaire (GSRS); social psychological functions via: sense of coherence-9 questionnaire (SOC-9); patient health questionnaire-9 questionnaire (PHQ-9), general anxiety disorder-7 questionnaire (GAD-7) ; post-traumatic embitterment disorder 21 questionnaire (PTED-21); work ability index questionnaire (WAI); body image scale questionnaire (BIS)). To our knowledge, this is the largest SPN cohort worldwide and the first study to concentrate on the quality of life of SPN after operations.

Interventions

OTHERobservational study

observational study

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* SPN patients with pathological diagnosis after surgery * Approval to participate * patients with valid and complete questionnaires results inspected by two experienced surgeons

Exclusion criteria

* Refusal to participate * patients with invalid or incomplete questionnaires results

Design outcomes

Primary

MeasureTime frameDescription
scores of digestive physiological and social psychological functionsup to 15 years after surgeryThe primary outcome is a score of digestive physiological and social psychological functions of SPN patients up to 15 years after surgery. The score is evaluated by a follow-up questionnaire made up of: digestive physiological functions via 8 symptoms scale of the EORTC core quality of life questionnaire and gastrointestinal symptom rating scale questionnaire; social psychological functions via sense of coherence-9, patient health questionnaire-9, general anxiety disorder-7; post-traumatic embitterment disorder 21; work ability index questionnaire, body image scale.R aw scores will undergo a linear transformation for standardization. The maximum and minimum score is 100 and 0, respectively. Higher scores on the digestive physiological and social psychological functioning scales represent better quality of life, whereas higher scores on the symptom scale represent more serious symptoms or poorer quality of life.

Secondary

MeasureTime frameDescription
progressive-free survivalthe time from the surgery to the progressive conditions (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to up 180 months)the time from the surgery to the progressive conditions (from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to up 180 months)

Countries

China

Contacts

Primary ContactQiaofei Liu
qfliu@aliyun.com8615201693370
Backup ContactJiayi Li
lijiayi_pumc@163.com8618801002019

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026