Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma

Официальное название

Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study

Обзор

The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.

Подробное описание

At present, the common used contrast agent in ERCP is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. When heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. And the applications of heated non-ionic contrast agents could be found in computed tomography angiography(CTA), hysterosalpingography (HSG) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. Nevertheless, heated contrast agent was rarely reported to act in ERCP. It's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control.

Вмешательства

• Процедура Injection of 37℃ contrast agent
  Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent

Первичные конечные точки

• Number of participants with Acute cholangitis [Срок оценки: 2 weeks]

Вторичные конечные точки (5)

• The ease of injection [Срок оценки: During procedures]
• Number of Participants With Abnormal Laboratory Values [Срок оценки: 4 days]
• Operation time [Срок оценки: intraoperative]
• X-ray exposure time [Срок оценки: intraoperative]
• Number of participants with Post-ERCP pancreatitis [Срок оценки: 1 months]

Критерии участия

Критерии включения

• Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
• Age: 18\~90 years old;
• Underwent diagnostic and therapeutic ERCP;

Критерии исключения

• Coagulation dysfunction(INR>1.3) or/and low peripheral blood platelet count （PLT <50x10\^9/L）;
• Preoperative acute cholangitis;
• Preoperative acute pancreatitis;
• Preoperative hemobilia or hemorrhage of digestive tract;
• Preoperative liver failure;
• Combined with Mirizzi syndrome and intrahepatic bile duct stones;
• Preoperative malignant tumor of biliary system such as carcinoma of head of pancreas, gallbladder carcinoma;
• Biliary-duodenal fistula confirmed during ERCP;
• A history of reconstructive surgery for upper digestive tract except Billroth Ⅰand a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum;
• Previous ERCP;
• Pregnant women

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• The first hospital of Lanzhou university — Lanzhou
• The first affiliated hospital of Xi 'an jiaotong university — Сиань
• Tianjin Nankai Hospital — Тяньцзинь

Идентификаторы

NCT: NCT03104569 · 37℃ Contrast Agent in ERCP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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