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Идёт набор NCT07100379

Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study

Без фазы С лечением Esophageal Atresia With Tracheo-esophageal Fistula Esophageal Atresia Esophageal Strictures

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: Endoscopic Balloon Dilation.
Кому может быть актуально
Состояния в реестре: Esophageal Atresia With Tracheo-esophageal Fistula, Esophageal Atresia, Esophageal Strictures. Базовые параметры: до 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Esophageal atresia (EA) is one of the most common gastrointestinal congenital anomalies that affects 1 in 2500 to 1 in 4000 live births. It is characterized by abnormal development of the esophagus, which requires surgical intervention to be compatible with life. Surgical repair of EA is associated with risk of developing esophageal strictures or narrowing, which nearly affects 40% of cases. Strictures can be treated using endoscopic balloon dilation, which consists of introducing a catheter with a balloon into the esophagus via endoscopy and positioning it across stricture followed by balloon inflation. The inflated balloon is held in position for a set amount of time with the goal to dilate the narrowed area. At this time there are no pediatric studies comparing difference balloon dilation times and outcomes. Our study's goal is to evaluate balloon dilation inflation time in treating esophageal anastomotic strictures to understand if inflation time is associated with outcome.

Вмешательства

  • Процедура Endoscopic Balloon Dilation
    Endoscopic balloon dilation is a routine procedure in which a catheter with a balloon is introduced into the esophagus to help treat esophageal strictures via endoscope. The catheter is placed directly across the span of the esophageal stricture and the balloon is inflated to pre-determined volume in order to dilate the esophageal stricture. Balloon will remain inflated for either 30 or 180 seconds based on patient's randomization.

Первичные конечные точки

  • Stricture response to endoscopic balloon dilation [Срок оценки: 6 months]
Вторичные конечные точки (1)
  • Change in esophageal anastomotic diameter [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Diagnosed with esophageal atresia with and without tracheoesophageal fistula, surgically repaired esophageal atresia, esophageal anastomotic strictures requiring endoscopic balloon dilation, and at least 1 endoscopic balloon dilation for esophageal anastomotic strictures within a 6 month period.

Критерии исключения

  • Patients who need endoscopic incisional therapy to manage anastomotic stricture during their first follow up endoscopy, patients requiring administration of intralesional steroid within 4 weeks of repair, have no follow up endoscopy within 6 months period, have any anastomosis type other than esophago-esophageal (e.g. jejunal or colonic interposition), and/or failure to meet target dilation time.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Boston Children's Hospital — Boston
  • Children's Hospital of Philadelphia — Philadelphia

Публикации

  • Khan AA, Shah SW, Alam A, Butt AK, Shafqat F, Castell DO. Pneumatic balloon dilation in achalasia: a prospective comparison of balloon distention time. Am J Gastroenterol. 1998 Jul;93(7):1064-7. doi: 10.1111/j.1572-0241.1998.00330.x. PMID 9672331
  • Wallner O, Wallner B. Balloon dilation of benign esophageal rings or strictures: a randomized clinical trial comparing two different inflation times. Dis Esophagus. 2014 Feb-Mar;27(2):109-11. doi: 10.1111/dote.12080. Epub 2013 Apr 26. PMID 23621385
  • Ten Kate CA, Tambucci R, Vlot J, Spaander MCW, Gottrand F, Wijnen RMH, Dall'Oglio L. An international survey on anastomotic stricture management after esophageal atresia repair: considerations and advisory statements. Surg Endosc. 2021 Jul;35(7):3653-3661. doi: 10.1007/s00464-020-07844-6. Epub 2020 Aug 3. PMID 32748272
  • Kovesi T, Rubin S. Long-term complications of congenital esophageal atresia and/or tracheoesophageal fistula. Chest. 2004 Sep;126(3):915-25. doi: 10.1378/chest.126.3.915. PMID 15364774
  • Castilloux J, Noble AJ, Faure C. Risk factors for short- and long-term morbidity in children with esophageal atresia. J Pediatr. 2010 May;156(5):755-60. doi: 10.1016/j.jpeds.2009.11.038. Epub 2010 Jan 31. PMID 20123142
  • Serhal L, Gottrand F, Sfeir R, Guimber D, Devos P, Bonnevalle M, Storme L, Turck D, Michaud L. Anastomotic stricture after surgical repair of esophageal atresia: frequency, risk factors, and efficacy of esophageal bougie dilatations. J Pediatr Surg. 2010 Jul;45(7):1459-62. doi: 10.1016/j.jpedsurg.2009.11.002. PMID 20638524
  • Krishnan U, Mousa H, Dall'Oglio L, Homaira N, Rosen R, Faure C, Gottrand F. ESPGHAN-NASPGHAN Guidelines for the Evaluation and Treatment of Gastrointestinal and Nutritional Complications in Children With Esophageal Atresia-Tracheoesophageal Fistula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):550-570. doi: 10.1097/MPG.0000000000001401. PMID 27579697

Идентификаторы

NCT: NCT07100379 · IRB-P00048288

Первоисточники (государственные реестры)

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