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Trial Title:
A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm
NCT ID:
NCT05593393
Condition:
IPMN, Pancreatic
Conditions: Official terms:
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Pancreatic Intraductal Neoplasms
Conditions: Keywords:
IPMN
clinical outcomes
EUS
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Endoscopic ultrasound
Description:
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.
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
Detailed description:
Baseline assessment will be conducted on IPMN patients who meet the inclusion conditions
and are included in the study with informed consent, including: ① demographic
characteristics (such as age, gender, etc.); ② Clinical features (such as symptoms,
complications, past history, family history, living/eating habits); ③ Characteristics of
laboratory indicators (such as pancreatic function, liver enzyme, bile duct enzyme,
CA199, CEA in blood; CA199, CEA in cystic fluid, etc.); ④ Imaging features * (such as
multiple or single lesions, diameter of cyst, whether there are mural nodules, diameter
of main pancreatic duct, etc.); ⑤ Endoscopic ultrasound (EUS) features * (such as: cyst
location, echo, maximum diameter, whether the cyst wall is thickened, wall nodules, the
connection between the cyst and the main pancreatic duct, laser confocal endoscopy
features, etc.); ⑥ Pathological information (cytology of cystic fluid; cytological smear
of cystic lesion puncture, histopathology); ⑥ Molecular characteristics of cyst fluid
(such as proteomics/mass spectrometry, new biomarkers, next generation sequencing (NGS),
flora characteristics, etc.); ⑦ Treatment information (such as current medication,
whether to have received endoscopic treatment, etc.).
The follow-up contents include: outpatient follow-up (symptoms, laboratory indicators;
keeping peripheral blood samples) every six months;, imaging follow-up (including
enhanced pancreatic MR and EUS imaging; the first pancreatic MRI follow-up was conducted
6 months after enrollment to determine the stability of the lesions) at baseline and
every 12 months thereafter.
During the follow-up, if the patient died of various causes, the follow-up will be
terminated; If enhanced nuclear magnetic resonance imaging or EUS imaging of the pancreas
indicates worrisome features (WFs) or high-risk features (High risk stigmata, HRS),
EUS-FNA ± nCLE should be performed (when performing EUS, perform contrast-enhanced
ultrasonography on cystic lesions with mural nodules, and collect cystic fluid when
puncturing some cystic lesions with sufficient volume).
If the cytological/histological pathological results of FNA indicate cancer or high grade
dysplasia (HGD), or/and cystic fluid cytological results are positive, surgical treatment
is recommended; If the FNA and cyst fluid cytology results are negative, the patients
with WF will be followed up 6 months later, while the HRS patients will be followed up 3
months later (whether to accept EUS examination is decided jointly by the follow-up
physician and the patient). It is suggested to review EUS-FNA ± nCLE according to the
imaging results. If the patient was advised to receive surgical treatment due to IPMN,
the follow-up was terminated.
Criteria for eligibility:
Study pop:
IPMN patients in Peking Union Medical College Hospital and other related research centers
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age: 18 years old or above;
2. Diagnosis: Imaging examination showed the presence of intraductal papillary mucinous
cystic tumor (IPMN) without high-risk features (including WF and HRS);
3. The patient or family members can understand the study protocol, are willing to
participate in the study, and provide written informed consent.
Exclusion Criteria:
1. 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;
2. Previous history of pancreatic malignant tumor;
3. 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;
4. 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;
5. The patient or family member could not understand the conditions and objectives of
this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 2022
Completion date:
September 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xiamen University
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/NCT05593393
