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临床试验/NCT05593393
NCT05593393尚未招募不适用

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

Peking Union Medical College Hospital0 个研究点目标入组 1,500 人开始时间: 2022年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
主要终点
The termination of the follow-up of IPMN patients, including death termination and recommended surgery termination.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 3 years

Patient died or was recommended for surgical treatment.

次要结局

  • The new development of worrisome features or high-risk stigmata(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Xi

associate professor

Peking Union Medical College Hospital

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