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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Enrolling

Conditions

Solid Pseudopapillary Tumor of the Pancreas
Pancreas Cancer

Treatments

Other: observational study

Study type

Observational

Funder types

Other

Identifiers

NCT05604716
S-K1034

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

SPN patients
Treatment:
Other: observational study

Trial contacts and locations

1

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Central trial contact

Qiaofei Liu; Jiayi Li

Data sourced from clinicaltrials.gov

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