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

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

NCT ID: NCT05604716

Condition: Solid Pseudopapillary Tumor of the Pancreas
Pancreas Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
Solid Pseudopapillary Neoplasm of the Pancreas
surgery
follow up
digestive physiological function
social psychological function

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Other
Intervention name: observational study
Description: observational study
Arm group label: SPN patients

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.

Criteria for eligibility:

Study pop:
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

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Peking Union Medical College Hospital

Address:
City: Beijing
Zip: 100730
Country: China

Status: Recruiting

Contact:
Last name: Qiaofei Liu, MD

Investigator:
Last name: Qiaofei Liu, MD
Email: Principal Investigator

Start date: January 1, 2001

Completion date: August 1, 2026

Lead sponsor:
Agency: Peking Union Medical College Hospital
Agency class: Other

Source: Peking Union Medical College Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05604716