Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) CPDPC16-03 Pediatric Longitudinal Cohort Study of Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 623
- 试验地点
- 22
- 主要终点
- Length of time from progression from Acute Recurrent Pancreatitis to Chronic Pancreatitis
研究概览
简要总结
The investigators will enroll a total of 628 patients under 18 years of age with ARP or CP. Included in the total are the 357patients in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years. Patient questionnaires and physician surveys will be applied at the time of enrollment and annually thereafter as long as possible. At the first study visit after turning 18 years of age, the patient will sign the informed consent to continue in the study. Specifically, the investigators will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.
详细描述
Disease Burden Pain. The pattern of the pain (constant versus episodic), its frequency, duration, visits to the emergency room or hospitalizations for pain, impact of pain on quality of life will be recorded in questionnaires. The intensity of the pain will be measured at enrollment, during an attack and annually using FACES Pain Scale-Revised, a self-report questionnaire validated for children >4 y/o. The names, dosing and frequency of medications taken for pain will also be queried.
Health-Related Quality of Life (HRQOL). An age-specific instrument validated for United States children will be used to measure HRQOL at enrollment and annually thereafter. Parents of children 5-18 years old will complete Child Health Questionnaire Parent Form 50 questions (CHQ PF-50). Children >10 years old will answer Child Health Questionnaire Child Form 87 questions (CHQ-87). Adults >18 years old will not complete a health-related questionnaire. These questionnaires capture physical functioning, social, emotional, physical and behavioral limitations, bodily pain, general behavior, mental health, self-esteem, general health perceptions, change in health and parental emotional impact.
Depression and anxiety. Depression and anxiety are strong predictors of chronic pain and pain-related disability in children, but it is not known whether this applies to children with ARP or CP. The investigators will assess for depression and anxiety in the INSPPIRE cohort at the time of enrollment and annually thereafter. The investigators will utilize the Child Behavioral Checklist (CBCL), one of the most widely-used standardized measures in child psychology for evaluating maladaptive behavioral and emotional problems in preschool subjects aged 1½ to 5 years and in school-age subjects between the ages of 6 and 18. For preschool-age children, the CBCL/1½-5 (completed by parents or surrogates) will be used. For school-age children 6-18 y/o, the investigators will utilize CBCL/6-18 y/o (completed by parents or surrogates). Children who are 11-18 y/o will answer a self-report questionnaire (Youth-Self Report Form or YSR/11-18). CBCL assesses internalizing (i.e., anxious, depressive, and over controlled) and externalizing (i.e., aggressive, hyperactive, noncompliant, and undercontrolled) behaviors. Adults >18 years old will not complete a behavioral checklist.
Patients/parents will spend approximately 2 hours answering questionnaires; their time will be compensated at $50 per visit. Patients will be enrolled during clinic visit as outpatient or as an inpatient. Alternatively, questionnaires can be applied over the phone or completed at home and returned via mail if the patient is unable to travel. Self-addressed stamped envelopes will be given to the patient/parent as needed for returning the questionnaires.
Disease Sequelae
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study.
- •2 Patients/parents must have signed an authorization for the release of their or their child's protected health information.
- •3 All children providing samples should fit the ARP or CP inclusion criteria defined below.
- •4 All children must be under 18 years of age at the time of enrollment.
- •Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
- •Abdominal pain compatible with AP,
- •Serum amylase and/or lipase values ≥3 times upper limits of normal,
- •Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections.
- •ARP is defined as:
- •At least 2 episodes of acute pancreatitis with complete resolution of pain and a >1 month pain-free interval between episodes.
- •Chronic Pancreatitis:
- •Children with at least:
- •One irreversible structural change* in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes.
- •*irreversible structural changes:
- •Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound (abd US), magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computerized tomography (CT), endoscopic retrograde cholangiopancreatography (ERCP), endoscopic US (EUS).
- •Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >2 months) on any imaging.
- •Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP.
- •Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages).
排除标准
- •Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study interventions.
结局指标
主要结局
Length of time from progression from Acute Recurrent Pancreatitis to Chronic Pancreatitis
时间窗: 3 years
Date of diagnosis of first acute pancreatitis to date of diagnosis of chronic pancreatitis presented as minimum, maximum, median number of days and no progression to chronic pancreatitis.
次要结局
- Number of emergency room visits subject had in whole life(18 years)
- Number of school days subject missed in the last month(30 days)
- Number of subjects with episodic abdominal pain(1 year)
- Number of hospitalizations subject had in past 12 months(1 year)
- Number of hospitalizations subject had in whole life(18 years)
- Number of subjects with abnormal fasting glucose(3 years)
- Number of subjects with abdominal pain(1 year)
- Number of subjects with abnormal hemoglobin A1c (HbA1c)(3 years)
- Number of subjects with constant abdominal pain(1 year)
- Number of emergency room visits subject had in the past 12 months(1 year)
- Number of subjects with Exocrine Pancreatic Insufficiency(3 years)
- Number of subjects with abnormal oral glucose tolerance test (OGTT)(3 years)
研究者
Aliye Uc
Professor
University of Iowa