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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05593393
Other study ID # K2378
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2022
Est. completion date September 2025

Study information

Verified date November 2022
Source Peking Union Medical College Hospital
Contact Xi Wu, M.D.
Phone 13683296860
Email wxpumch@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Endoscopic ultrasound
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.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Peking Union Medical College Hospital Beijing Hospital, The First Affiliated Hospital of Xiamen University, Tongji Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The new development of worrisome features or high-risk stigmata High-risk stigmata refers to obstructive jaundice, enhancing mural nodules or an associated solid component, and those with an MPD =10 mm. Worrisome features refer to acute pancreatitis, cyst size =30 mm, thickened/enhancing cyst wall, MPD measuring 5-9.9 mm, nonenhancing mural nodules, and abrupt change in MPD caliber with distal atrophy of the pancreatic gland. 3 years
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06283576 - Pancreatic Cancer Initial Detection Via Liquid Biopsy
Not yet recruiting NCT06276764 - The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
Active, not recruiting NCT04207944 - The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial) Phase 2
Recruiting NCT05117723 - Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer