Metabolic Impact of Pancreatic Duct Decompression
Metabolic Impact of Endoscopic Pancreatic Duct Decompression: A Pilot Study
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This single-center randomized controlled trial will compare endoscopic pancreatic duct decompression with medical management alone for the treatment of pancreatic duct obstruction in patients with minimally symptomatic chronic pancreatitis. Utilizing mixed-meal tolerance testing, endocrine function will be assessed at baseline and 6-months post-randomization. We hypothesize that rigorous metabolic testing using mixed-meal tolerance testing at baseline and 6-months post-randomization will be feasible.
The study intervention entails endoscopic pancreatic duct decompression which entails endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shock wave lithotripsy (ESWL). Endoscopic treatment via ERCP ± ESWL will continue until pancreatic duct decompression is achieved. The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Luis Ospina, BS
- Номер телефона: 507-538-1827
- Электронная почта: OspinaVelasquez.Luis@mayo.edu
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18
- Chronic pancreatitis as defined by Cambridge grade 3 or 4 (3: > 3 abnormal side branches; 4: abnormal main duct and branches) pancreatic ductal changes and/or parenchymal and/or intraductal calcifications (chronic calcific pancreatitis) by CT Scan or MRI/MRCP24
Minimally symptomatic:
- Asymptomatic patients who were incidentally diagnosed with chronic pancreatitis based on imaging
- Mild to moderate pain (visual analog scale ≤ 5) who do not require daily opioid pain medications
- ≤ 1 episode of uncomplicated acute pancreatitis in 12 months prior to enrollment
Exclusion Criteria:
- History of diabetes (defined as either a HbA1c ≥ 6.5 % or a fasting glucose ≥ 126 mg/dL)
- Pancreatic duct obstruction limited to the tail of pancreas
- Surgically altered forgot anatomy prohibitive of ERCP with standard techniques (e.g Billroth II, Roux-en-y gastric bypass, pancreaticoduodenectomy)
- Prior pancreatic surgery
- Pancreatic head mass or suspicion for pancreatic malignancy
- Concurrent extra-pancreatic malignancy other than non-melanoma skin cancer
- Prior endoscopic therapy for pancreatic duct obstruction
- Acute pancreatitis < 90 days prior to enrollment
- Active alcohol use within 2 months of enrollment
- Gastrointestinal stricture/obstruction precluding passage of the duodenoscope to the papilla
- Standard contraindications to ERCP
- Unable to receive general anesthesia
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Endoscopic pancreatic duct decompression (Intervention Arm)
Participants in the intervention arm will receive endoscopic pancreatic duct decompression.
|
The study intervention is endoscopic pancreatic duct decompression, which will consist of endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shockwave lithotripsy (ESWL).
Treatment via ERCP +/- ESWL can be continued for multiple treatment sessions until the pancreatic duct has been decompressed, defined as complete resolution of the PD stricture (defined as > 90% resolution of the stenosis on pancreatography) and/or complete stone clearance (> 90% removal of PD stones) of any PD stones.
Pancreatoscopy-guided lithotripsy can be performed during ERCP as well to help aid in stricture or stone therapy.
|
|
Без вмешательства: No endoscopic intervention (Control Arm)
The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasibility of performing randomized-controlled trial in patients with minimally symptomatic chronic pancreatitis to assess metabolic function as defined via enrollment ratio, retention rate, and assessment completion rate.
Временное ограничение: From enrollment to 6 months post-randomization
|
Feasibility will be defined as follows: For the study enrollment ratio, the total number of participants referred will form the denominator for the enrollment ratio, while the number of enrolled will form the numerator for the enrollment ratio. A 50% enrollment ratio will be indicative of feasibility. Retention will be determined by the proportion of enrolled participants who remain in the study until completion of endotherapy and the end of assessment period. A 75% retention rate will be indicative of feasibility. Assessment completion will be defined as completion of all baseline assessments and 6-months post-randomization assessments, including all metabolic tests. Participants who complete all assessments represent the numerators in the assessment completion ratio with the number of participants enrolled serving as the denominator in the assessment completion ratio. A 70% completion rate will indicate feasibility. |
From enrollment to 6 months post-randomization
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion.
Временное ограничение: From enrollment to 6 months post-randomization
|
The secondary endpoint will be the change in insulin secretion from baseline to 6-months post-randomization for each treatment arm. Insulin secretion will be measured using mixed meal tolerance testing, which will be performed at baseline and 6-months post-randomization, during which serum C-peptide, insulin and glucose levels will be measured. Insulin secretion will be calculated using the Area Under the Curve (AUC) of C-peptide. This will be calculated using the trapezoidal method. An AUC of the fasting serum glucose levels will be calculated in similar fashion. Insulin secretion will then be estimated by dividing the AUC for C-peptide by the AUC for glucose. |
From enrollment to 6 months post-randomization
|
|
Impact of pancreatic duct decompression on pancreatic exocrine function as measured by fecal elastase.
Временное ограничение: From enrollment to 6-months post-randomization
|
Another secondary objective is to evaluate the impact of pancreatic duct decompression on pancreatic exocrine function, as measured using the fecal elastase test.
The change in fecal elastase levels from baseline to 6-months post-randomization will be compared between treatment groups to assess the change in pancreatic exocrine function.
|
From enrollment to 6-months post-randomization
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Samuel Han, MD, Mayo Clinic
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Патологические процессы
- Хроническое заболевание
- Атрибуты болезни
- Метаболические заболевания
- Заболевания пищеварительной системы
- Нарушения метаболизма глюкозы
- Заболевания поджелудочной железы
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Панкреатит
- Панкреатит, хронический
- Сахарный диабет
Другие идентификационные номера исследования
- 26-005624
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Researchers will be able to access the IPD after submitting a proposal that is reviewed and approved by the PI.
Deidentified data in accordance to the agreed-upon proposal will be made available to researchers.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- АНАЛИТИЧЕСКИЙ_КОД
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .