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

NCT05604716 | Recruiting DMC

• 1 other identifier: S-K1034
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Pseudopapillary Tumor of the Pancreas; Pancreas Cancer

Keywords

Solid Pseudopapillary Neoplasm of the Pancreas; surgery; follow up; digestive physiological function; social psychological function

Outcome Measures

Primary Outcomes (1)

• scores of digestive physiological and social psychological functions

  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.

  up to 15 years after surgery

Secondary Outcomes (1)

• 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)

Study Arms (1)

SPN patients

Other: observational study

Interventions

observational study OTHER

observational study

SPN patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Qiaofei Liu

  Department of General Surgery, Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Qiaofei Liu

CONTACT

8615201693370; qfliu@aliyun.com

Jiayi Li

CONTACT

8618801002019; lijiayi_pumc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical chief professor

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 3, 2022
• Study Start: January 1, 2001
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)