PRospective Registry of Esophageal Motility
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: No intervention.
- Кому может быть актуально
- Состояния в реестре: Esophageal Diseases, Achalasia, Eosinophilic Esophagitis, Motility Disorder. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Digestive physiopathology is a branch of gastroenterology aiming to study patients with upper GI symptoms, mainly gastro-esophageal, potentially indicating the presence of Gastroesophageal Reflux Disease (GERD)/Barrett Esophagus (BE) or obstructive esophageal motility disorders (achalasia being the most relevant), but including also other primary motility disorders such as Esophgago-Gastric Junction Outflow Obstruction (EGJOO), Hypercontractile Esophagus (HE), Distal Esophageal Spasm (DES) and other minor disorders. Physiopathological testing encompasses High-Resolution Manometry (HRM), 24-H esophageal pH-impedance testing, Functional Lumen Imaging Probe (FLIP) assessment. All these tests are designed to provide a clear phenotyping of esophago-gastric disorders related to reflux or obstructive esophageal symptoms, either in naïve patients, as well as after foregut surgery (particularly anti-reflux surgery, achalasia/primary motility disorders treatment).
Подробное описание
Digestive physiopathology is a branch of gastroenterology aiming to study patients with upper GI symptoms, mainly gastro-esophageal, potentially indicating the presence of Gastroesophageal Reflux Disease (GERD)/Barrett Esophagus (BE) or obstructive esophageal motility disorders (achalasia being the most relevant), but including also other primary motility disorders such as Esophgago-Gastric Junction Outflow Obstruction (EGJOO), Hypercontractile Esophagus (HE), Distal Esophageal Spasm (DES) and other minor disorders. Physiopathological testing encompasses High-Resolution Manometry (HRM), 24-H esophageal pH-impedance testing, Functional Lumen Imaging Probe (FLIP) assessment. All these tests are designed to provide a clear phenotyping of esophago-gastric disorders related to reflux or obstructive esophageal symptoms, either in naïve patients, as well as after foregut surgery (particularly anti-reflux surgery, achalasia/primary motility disorders treatment).
Primary objective of the study is to create a prospective/retrospective registry of all patients with \> 18 years of age referring to the Digestive Physiopathology division of San Raffaele Hospital, in order to register clinical, endoscopic, radiologic data of these patients integrating them with physiopatology outcomes in order to shape disease management and treatment work-up, also in long-term follow-up of these patients.
Primary endpoints are the Integration and analysis of association/correlation of physiologic with endoscopic, radiologic and clinical data.
PREM is a prospective registry recruiting patients retrospectively enrolled aiming\[RT1.1\] to include all clinical, endoscopic, radiological integrating them with physiopathology data of all patients referred to Digestive Physiopathology Division of San Raffaele Hospital, with the purpose of extracting data for prospective and retrospective analyses, in order to improve patients' management and clinical research and empower diagnostic and therapeutic work-up
Вмешательства
- Другое No intervention
No intervention
Первичные конечные точки
- To collect High Resolution Manometry (HRM) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect pH-impedance data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
Вторичные конечные точки (12)
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect esophago-gastro-duodenoscopy (EGD) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect radiological (TBE, barium esophagogram) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect anamnestic, clinical data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
- To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital [Срок оценки: 2026-2031]
Критерии участия
Критерии включения
- Participant is willing and able to give informed consent for participation in the study.
- The procedures are the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
- Aged > 18 years.
- Any typical (heartburn or regurgitation) or atypical reflux symptom (Laryngeal Cough, laryngitis, sub-glottic stenosis, globus, laryngeal cancer, vocal cord granuloma, vocal cord irritation, vocal cord polyps and post-nasal drip; Oropharyngeal: Dental erosion, pharyngitis, sore or burning throat, gingivitis and halitosis; Ears and sinuses: Earaches, otitis media and sinusitis; Pulmonary: Chronic bronchitis, pneumonia, aspiration, bronchiectasis, asthma and idiopathic pulmonary fibrosis; Cardiac: Arrhythmia, angina and myocardial infarction; Sleep: Sleep apnoea, sleep deprivation, insomnia, snoring, nightmare and sleep disturbance), but also any obstructive esophageal symptom potentially reflecting a primary or secondary motility disorder (oropharyngeal or esophageal dysphagia, chest pain, bolus impaction). Every patient with a diagnosis of esophageal inflammatory disorder (including EoE and others) or systemic rheumatological condition (scleroderma, systemic sclerosis, lichen planus and others), every patient previously undergone to any anti-reflux surgery, bariatric surgery, endoscopic or surgical esophageal or gastric myotomy (also for gastroparesis) may be included.
- Patients must be referred to the Digestive Physiopathology Unit of IRCCS San Raffaele Hospital for motility tests
Критерии исключения
- Age < 18 years
- Not willing to provide informed consent to the inclusion in the registry
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- IRCCS San Raffaele Hospital — Milan
Публикации
- Carlson DA, Kahrilas PJ, Lin Z, Hirano I, Gonsalves N, Listernick Z, Ritter K, Tye M, Ponds FA, Wong I, Pandolfino JE. Evaluation of Esophageal Motility Utilizing the Functional Lumen Imaging Probe. Am J Gastroenterol. 2016 Dec;111(12):1726-1735. doi: 10.1038/ajg.2016.454. Epub 2016 Oct 11. PMID 27725650
- Salvador R, Pandolfino JE, Costantini M, Gyawali CP, Keller J, Mittal S, Roman S, Savarino EV, Tatum R, Tolone S, Zerbib F, Capovilla G, Jain A, Kathpalia P, Provenzano L, Yadlapati R; HRM & Foregut Surgery International Working Group. The Role of High-Resolution Manometry Before and Following Antireflux Surgery: The Padova Consensus. Ann Surg. 2025 Jan 1;281(1):124-135. doi: 10.1097/SLA.000000000 PMID 38606560
- Yadlapati R, Kahrilas PJ, Fox MR, Bredenoord AJ, Prakash Gyawali C, Roman S, Babaei A, Mittal RK, Rommel N, Savarino E, Sifrim D, Smout A, Vaezi MF, Zerbib F, Akiyama J, Bhatia S, Bor S, Carlson DA, Chen JW, Cisternas D, Cock C, Coss-Adame E, de Bortoli N, Defilippi C, Fass R, Ghoshal UC, Gonlachanvit S, Hani A, Hebbard GS, Wook Jung K, Katz P, Katzka DA, Khan A, Kohn GP, Lazarescu A, Lengliner J, PMID 33373111
Идентификаторы
NCT: NCT07506746 · PREM