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

NCT ID: NCT05604716

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-01

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Solid Pseudopapillary Tumor of the Pancreas Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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SPN patients

observational study

Intervention Type OTHER

observational study

Interventions

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observational study

observational study

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiaofei Liu

clinical chief professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiaofei Liu

Role: STUDY_CHAIR

Department of General Surgery, Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiaofei Liu

Role: CONTACT

8615201693370

Jiayi Li

Role: CONTACT

8618801002019

Facility Contacts

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Qiaofei Liu, MD

Role: primary

Other Identifiers

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S-K1034

Identifier Type: -

Identifier Source: org_study_id

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