EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis

Официальное название

Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis

Обзор

The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.

Подробное описание

Chronic pancreatitis is a complex fibroinflammatory disease arising from numerous etiological factors and a variety of clinical manifestations. Abdominal pain is the most debilitating complication and can result in significant morbidity and impact on quality of life. Endoscopic ultrasonography (EUS) has been increasingly utilized for celiac plexus block (EUS-CPB), whereby a steroid in combination with a local anesthetic agent are injected into the celiac plexus within the abdominal cavity. The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.

Вмешательства

• Процедура EUS-guided celiac plexus block
  Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.
• Процедура Sham procedure
  Celiac plexus will not be performed in this arm.

Первичные конечные точки

• Rate of adequate pain relief [Срок оценки: 1 month]

Вторичные конечные точки (11)

• Technical success [Срок оценки: Immediately after procedure]
• Pain scores measured using Visual Analog Scale. [Срок оценки: 3 months]
• Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form. [Срок оценки: 3 months]
• Quality of life assessment [Срок оценки: 3 months]
• Opioid analgesic use [Срок оценки: 3 months]
• Procedure-related adverse events [Срок оценки: 3 months]
• Disease-related adverse events [Срок оценки: 3 months]
• Hospital admissions for management of chronic pancreatitis. [Срок оценки: 3 months]
• Length of hospitalization in any patient hospitalized [Срок оценки: 3 months]
• Rate of cross-over to EUS-CPB in patients initially assigned to the sham group. [Срок оценки: 3 months]
• Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis. [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Abdominal pain of at least 3 months duration and a VAS score ≥ 3, with or without the use of narcotic analgesics.
• Diagnosis of chronic pancreatitis on EUS examination, with ≥ 5 features on EUS.
• No other cause of abdominal pain

Критерии исключения

• Age < 18 years.
• History of prior EUS-CPB.
• Use of anticoagulants that cannot be discontinued for the procedure.
• Clinically significant allergy to bupivacaine or triamcinolone.
• Unable to obtain consent for the procedure from either the patient or LAR.
• Intrauterine pregnancy.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Orlando Health — Orlando

Публикации

• Wilcox CM, Bang JY, Buxbaum J, Gardner TB, Hawes R, Kedia P, Mardini SH, Muniraj T, Navaneethan U, Oza VM, Tarnasky P, Thakkar S, Waxman I, Varadarajulu S; US Pancreatic Disease Study Group. Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial 1. Trials. 2024 Oct PMID 39396987

Идентификаторы

NCT: NCT06178315 · 2103069

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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