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Набор скоро начнётся NCT07093996

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis

Без фазы С лечением Acute Pancreatitis (AP)

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 pancreatic duct stent placement, Conventional treatment of acute pancreatitis in early phase.
Кому может быть актуально
Состояния в реестре: Acute Pancreatitis (AP). 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
Китай, Россия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis: International Multicenter Controlled Randomized Prospective Study Protocol

Обзор

The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.

Подробное описание

Endoscopic pancreatic duct stent placement is used to treat a variety of pancreatic diseases, including chronic pancreatitis, Wirsung duct strictures, pseudocysts in disconnected duct syndrome and as a preventive measure after endoscopic retrograde cholangiopancreatography. Despite the obvious progress, the greatest number of unsolved problems remain in the issues of using this manipulation in patients with acute pancreatitis. In particular, the perspectives of the pancreatic duct stent placement in treatment of acute pancreatitis early stages remain controversial.

On the one hand, the installation of a stent in the early acute pancreatitis stages helps to normalize the outflow of pancreatic juice from the pancreas and reduce intraductal pressure, leading to a beneficial effect, as evidenced by a number of researchers. On the other hand, stent placement may partially block the second-order pancreatic ducts or increase the risk of sterile pancreatitis contamination due to the development of reflux. In addition, one should not forget about a number of post-manipulation complications inherent in this procedure, including bleeding from the area of the major duodenal papilla, perforation of the duodenum, progression of pancreatic necrosis and cholangitis. Finally, the timing and indications for early endoscopic stenting of the pancreatic duct are not currently standardized, largely due to the fact that acute pancreatitis is a pathological condition that is difficult to predict.

Thus, although this manipulation seems perspective, due to the lack of evidence base, it is currently difficult to recommend it for use in wide clinical practice.

The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.

Вмешательства

  • Процедура Endoscopic pancreatic duct stent placement
    Endoscopic pancreatic duct stent placement will be performed with a 5Fr Boston Scientific pancreatic stent (3-4 cm in length) within 24 hours from the randomization procedure. The stent will be removed on the 5th day after installation.
  • Препарат Conventional treatment of acute pancreatitis in early phase
    Infusion therapy, pain relief, nutritional support and surgical procedure if needed

Первичные конечные точки

  • Mortality rate [Срок оценки: From enrollment to the end of treatment at 3 months]
Вторичные конечные точки (8)
  • Incidence of complications associated with endoscopic pancreatic duct stent placement [Срок оценки: From endoscopic pancreatic duct stent placement to 3 months]
  • Rate of different pancreatic necrosis models [Срок оценки: From enrollment to the 7th day of treatment]
  • Average Balthazar computed tomography severity index (0-10) [Срок оценки: From enrollment to the 7th day of treatment]
  • Average SOFA (Sequential Organ Failure Assessment Score) score (0-24) [Срок оценки: From enrollment to the 7th day of treatment]
  • Incidence of other surgical interventions [Срок оценки: From enrollment to the end of treatment at 3 months]
  • Number of participants with other surgical interventions [Срок оценки: From enrollment to the end of treatment at 3 months]
  • Length of hospital stay [Срок оценки: From date of hospitalization until the date of discharge, assessed up to 3 months]
  • Number of participants with manifestation of diabetes mellitus [Срок оценки: From enrollment to the end of treatment at 3 months]

Критерии участия

Критерии включения

  • Diagnosis of acute pancreatitis confirmed on the basis of at least 2 of the 3 diagnostic criteria according to the revised Atlanta classification
  • Presence of organ failure signs (moderate and severe pancreatitis)
  • Informed consent of the patient

Критерии исключения

  • Presence of other indications for endoscopic intervention on the major duodenal papilla (biliary pancreatitis with cholangitis, calculus of the major duodenal papilla, stenosis of the major duodenal papilla, etc.)
  • Previous surgical interventions on the major duodenal papilla
  • Diverticula of the major duodenal papilla
  • Pregnancy
  • Shock
  • Coagulopathy (INR>1.5, blood platelets < 50\*109/l

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
Открытое
Основная цель
Лечение

Центры проведения

Россия · 6 центров
  • City Clinical Hospital No. 4 — Perm
  • Almazov National Medical Research Centre — Saint Petersburg
  • The City Hospital of the Holy Martyr Elizabeth — Saint Petersburg
  • I.I. Dzhanelidze research institute of emergency medicine — Saint Petersburg
  • Mariinskaya Hospital — Saint Petersburg
  • Volgograd State Medical University — Volgograd
Китай · 1 центр
  • Department of General Surgery, Sir Run Run Shaw Hospital — Ханчжоу

Публикации

  • Leppaniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019. PMID 31210778
  • ASGE Standards of Practice Committee; Anderson MA, Fisher L, Jain R, Evans JA, Appalaneni V, Ben-Menachem T, Cash BD, Decker GA, Early DS, Fanelli RD, Fisher DA, Fukami N, Hwang JH, Ikenberry SO, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA. Complications of ERCP. Gastrointest Endosc. 2012 Mar;75(3):467-73. doi: 10.1016/j.gie.2011.07.010. No abstract availa PMID 22341094

Идентификаторы

NCT: NCT07093996 · 14061979

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗