Prevalence and Predictive Factors of Difficult Biliary Cannulation
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Difficult Biliary Cannulation. 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prevalence and Predictive Factors of Difficult Biliary Cannulation: a Multicenter Study
Обзор
The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well as the predictive factors for this event in a prospective, multicenter study. Consecutive patients undergoing ERCP will be included in the study We will also assess: Evaluate the failure of biliary cannulation in our setting. Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria. Design an "a priori" predictive model for difficult cannulation and cannulation failure. Cost study: record of materials used.
Подробное описание
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.
After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.
Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation and the number of independent variables associated in the multiple logistic regression-the need to include a larger number of patients. For each variable included in the multiple logistic regression analysis, 8 to 10 cases of patients with difficult cannulation would be required.
Первичные конечные точки
- Difficult biliary cannulation [Срок оценки: 1 year]
Вторичные конечные точки (4)
- Failure of biliary cannulation [Срок оценки: 1 year]
- Predictive factors for difficult cannulation and cannulation failure [Срок оценки: 1 year]
- Designing an "a priori" predictive model for difficult cannulation and cannulation failure [Срок оценки: 1 year]
- To carry out a cost study [Срок оценки: 1 year]
Критерии участия
Критерии включения
- Age >18 years
- Signed informed consent
- Patients indicated for ERCP
Критерии исключения
- INR > 1.5
- Platelets < 50,000/mm³
- Patients with a prior endoscopic sphincterotomy
- Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
- Known pancreas divisum
- Indication due to pancreatic duct pathology
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Baron TH, Petersen BT, Mergener K, Chak A, Cohen J, Deal SE, Hoffinan B, Jacobson BC, Petrini JL, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for endoscopic retrograde cholangiopancreatography. Am J Gastroenterol. 2006 Apr;101(4):892-7. doi: 10.1111/j.1572-0241.2006.00675.x. No abstract available. PMID 16635233
- Caceres-Escobar D, Munoz-Velandia OM, Vargas-Rubio R. FACTORS ASSOCIATED WITH DIFFICULT BILIARY CANNULATION IN A TRAINING CENTER FOR ENDOSCOPIC INTERVENTION OF THE BILIARY TRACT. Arq Gastroenterol. 2022 Jan-Mar;59(1):29-34. doi: 10.1590/S0004-2803.202200001-06. PMID 35442332
- Dalal A, Gandhi C, Patil G, Kamat N, Vora S, Maydeo A. Safety and efficacy of different techniques in difficult biliary cannulation at endoscopic retrograde cholangiopancreatography. Hosp Pract (1995). 2022 Feb;50(1):61-67. doi: 10.1080/21548331.2022.2029451. Epub 2022 Jan 20. PMID 35025705
- Saito H, Kadono Y, Shono T, Kamikawa K, Urata A, Nasu J, Imamura H, Matsushita I, Kakuma T, Tada S. Factors Predicting Difficult Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography for Common Bile Duct Stones. Clin Endosc. 2022 Mar;55(2):263-269. doi: 10.5946/ce.2021.153. Epub 2021 Nov 12. PMID 34763384
Идентификаторы
NCT: NCT06591364 · PRECABIDO