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临床试验/NCT05604716
NCT05604716招募中不适用

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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2001年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
scores of digestive physiological and social psychological functions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

scores of digestive physiological and social psychological functions

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiaofei Liu

clinical chief professor

Peking Union Medical College Hospital

研究点 (1)

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