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

Recruiting

• Conditions: Solid Pseudopapillary Tumor of the Pancreas; Pancreas Cancer
• Interventions: Other: observational study

• Registration Number: NCT05604716
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2001-01-01
• Study First Submitted: 2022-10-10
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-01
• Last Update Submitted: 2022-11-01
• Study First Posted: 2022-11-03
• Last Update Posted: 2022-11-03
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SPN patients	observational study	-

Primary Outcome Measures

Name	Time	Method
scores of digestive physiological and social psychological functions	up to 15 years after surgery	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.

Secondary Outcome Measures

Name	Time	Method
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)	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)

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China