A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm

NCT05593393 | Unknown

• 1 other identifier: K2378
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study objective: To establish a long-term follow-up cohort of patients with IPMN, study the follow-up, clinical outcomes and prognostic factors of patients with IPMN, and provide a basis for clinical decisions and guidelines. Study design: This is a real world, multicenter, prospective, observational cohort study

Conditions

IPMN, Pancreatic

Keywords

IPMN; clinical outcomes; EUS

Outcome Measures

Primary Outcomes (1)

• The termination of the follow-up of IPMN patients, including death termination and recommended surgery termination.

  Patient died or was recommended for surgical treatment.

  3 years

Secondary Outcomes (1)

• The new development of worrisome features or high-risk stigmata

  3 years

Interventions

Endoscopic ultrasound DEVICE

The EUS follow-up will be conducted at baseline and every 12 months thereafter. For patients with new WF or HRS in the evaluation, the follow-up physician and the patient can jointly decide whether to perform EUS evaluation in the 6 or 3 month intensive follow-up.

Eligibility Criteria

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

Study Population

IPMN patients in Peking Union Medical College Hospital and other related research centers

You may qualify if:

• Age: 18 years old or above;
• Diagnosis: Imaging examination showed the presence of intraductal papillary mucinous cystic tumor (IPMN) without high-risk features (including WF and HRS);
• The patient or family members can understand the study protocol, are willing to participate in the study, and provide written informed consent.

You may not qualify if:

• The patient's clinical, imaging and auxiliary examination characteristics conform to the surgical indications of the International Association of Pancreatic Diseases (IAP) 2018 guidelines, and the patient has no surgical contraindication;
• Previous history of pancreatic malignant tumor;
• There were the following worrisome features (WF) of IPMN found in the past examination: acute pancreatitis, cyst size ≥ 30mm, cyst wall thickening/strengthening, main pancreatic duct diameter of 5-9.9mm, non enhanced mural nodules, sudden change of main pancreatic duct diameter with distal pancreatic atrophy;
• The following high risk features of IPMN (HRS) were found in the past: obstructive jaundice, enhanced mural nodules or related solid components, and main pancreatic duct\>10mm;
• The patient or family member could not understand the conditions and objectives of this study.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Hospital: collaborator
• Tongji Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Baseline sample includes 20ml blood sample, 1 oral flora swab and 1 stool sample. Follow-up samples include 10mL blood sample and remaining samples of pancreatic puncture tissue and/or cyst fluid during EUS

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Xi Wu, M.D.

  Peking Union Medical College Hospital

  STUDY DIRECTOR

• Shengyu Zhang, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Yiran Su, MD candidate

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Wu, M.D.

CONTACT

13683296860; wxpumch@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 25, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 14, 2022

Record last verified: 2022-11