Cross-sectional Follow-up on Digestive and Social Functions of SPN
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
SPN patients with pathological diagnosis after surgery
Approval to participate
patients with valid and complete questionnaires results inspected by two experienced surgeons
Disqualifiers
Refusal to participate
patients with invalid or incomplete questionnaires results
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
observational study
Other interventionobservational study
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: SPN patients1 intervention
Trial outcomes
Primary outcomes
1
scores of digestive physiological and social psychological functions
The 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.
Time frame
up to 15 years after surgerySecondary outcomes
1
progressive-free survival
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)
Time frame
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)Sponsors and contacts
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Source ClinicalTrials.gov