IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN Under Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Association between clinically relevant PEI and IPMN progression during follow-up
研究概览
简要总结
Intraductal Papillary Mucinous Neoplasms (IPMN) are pancreatic cystic neoplasms managed through imaging-based surveillance focused on oncologic risk. However, IPMN pathophysiology includes ductal obstruction by mucin, chronic ductal hypertension, and progressive parenchymal atrophy, mechanisms that may lead to pancreatic exocrine insufficiency (PEI).
PEI is a maldigestion syndrome typically associated with chronic pancreatitis, pancreatic cancer, and pancreatic surgery, but it has never been systematically investigated in patients with IPMN under surveillance.
The IPEX study is a multicenter prospective observational cohort study designed to evaluate whether PEI is prevalent in IPMN patients and whether it correlates with morphologic disease progression. The study also evaluates the potential role of PEI as a functional marker complementary to imaging criteria in IPMN surveillance.
详细描述
progression in patients diagnosed with branch-duct, main-duct, or mixed-type IPMN undergoing routine surveillance.
PEI will be assessed using a composite clinical-biochemical definition based on fecal elastase-1 (FE-1) levels and standardized clinical evaluation through a pancreatology visit and PEI Symptom Score (PSS).
IPMN progression will be defined according to the development of worrisome features (WF), high-risk stigmata (HRS), need for intensified surveillance, referral to surgery, histologic high-grade dysplasia/carcinoma, or diagnosis of concomitant pancreatic ductal adenocarcinoma.
The study does not introduce any intervention beyond standard care and aims to determine whether PEI represents a marker of functional pancreatic deterioration associated with IPMN evolution.
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
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN
- •Under active imaging surveillance
- •Signed informed consent
排除标准
- •Prior pancreatic surgery
- •Chronic pancreatitis
- •Known pancreatic ductal adenocarcinoma at baseline
- •Other established causes of PEI unrelated to IPMN
研究组 & 干预措施
IPMN
This study includes a single prospective observational cohort of adult patients (≥18 years) with a diagnosis of intraductal papillary mucinous neoplasm (IPMN)-including branch-duct, main-duct, or mixed-type.
Participants are managed according to standard-of-care IPMN surveillance protocols (MRI/MRCP ± EUS), with no mandated interventional treatment. In parallel, patients undergo a structured pancreatology assessment to evaluate pancreatic exocrine function.
The exposure of interest is pancreatic exocrine insufficiency (PEI), defined using a composite clinical-biochemical criterion based on fecal elastase-1 (FE-1) levels and standardized clinical and nutritional parameters. No experimental intervention is administered; initiation of pancreatic enzyme replacement therapy (PERT), when clinically indicated, is recorded but not protocol-driven.
结局指标
主要结局
Association between clinically relevant PEI and IPMN progression during follow-up
时间窗: Day 1 and after 6 and 12 months
Clinically relevant PEI defined as: * FE-1 \<100 µg/g OR * FE-1 100-200 µg/g plus ≥1 clinical criterion IPMN progression defined by WF/HRS development, surgical referral, or histologic progression
次要结局
- Prevalence and incidence of PEI in IPMN patients(Day 1 and after 6 and 12 months)
- Association between imaging parameters (MPD diameter, parenchymal atrophy) and PEI(Day 1 and after 6 and 12 months)
- Time-to-progression stratified by PEI status(Day 1 and after 6 and 12 months)
- Nutritional impact of PEI(Day 1 and after 6 and 12 months)
- Incremental predictive value of PEI beyond imaging criteria(Day 1 and after 6 and 12 months)