Clinical trial NCT05604716: Cross-sectional Follow-up on Digestive and Social Functions of SPN
Official title: An Observational Cross-sectional Follow-up Study on Digestive Physiological and Social Philosophical Functions of Solid Pseudopapillary Neoplasm of the Pancreas (SPN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Pseudopapillary Tumor of the Pancreas
Pancreas Cancer
Keywords: Solid Pseudopapillary Neoplasm of the Pancreas
surgery
follow up
digestive physiological function
social psychological function
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the hospitalized patients of SPN with a definite pathological diagnosis who underwent operations from 2001 to 2026 in Peking Union Medical College Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: scores of digestive physiological and social psychological functions
timeFrame: up to 15 years after surgery
Secondary outcomes:
measure: progressive-free survival
timeFrame: 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)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Department of General Surgery, Peking Union Medical College Hospital
name: Qiaofei Liu
role: STUDY_CHAIR
References: