a long-term follow-up cohort study in patients with intraductal papillary mucinous neoplasm

Conditions: IPMN, Pancreatic

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

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.

Eligibility 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.

Keywords: ipmn clinical outcomes eus