A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension
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: Splenectomy, Control.
- Кому может быть актуально
- Состояния в реестре: Acute Necrotizing Pancreatitis, Portal Hypertension. Базовые параметры: 18 лет — 75 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
- 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
The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension
Обзор
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The study aims to study the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH.
Подробное описание
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). A total of 66 participants are planned to be enrolled. The study aims to compare the outcomes of two surgical approaches: open debridement combined with distal pancreatectomy and total splenectomy versus open debridementalone. The objective is to observe the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH. The primary observational indicators include postoperative length of hospital stay, postoperative cost, postoperative life quality, and the alleviation of PSPH. Secondary observational indicators encompass the number of unplanned reoperations, postoperative infection control, postoperative irrigation volume, postoperative antibiotic consumption, and postoperative platelet count change. The study will be carried out in accordance with the protocol.
Вмешательства
- Процедура Splenectomy
Open Debridement combined with distal pancreatectomy and total splenectomy - Процедура Control
Open Debridement alone
Первичные конечные точки
- Length of hospital stay after debridement [Срок оценки: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
- Degree of pancreatic sinistral portal hypertension [Срок оценки: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
Вторичные конечные точки (11)
- Intensive Care Unit stay post Operation [Срок оценки: Perioperative]
- Pancreatic Fistula [Срок оценки: Perioperative]
- Number of Draining Tube when Discharged [Срок оценки: Perioperative]
- Time of all draining tubes removal [Срок оценки: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
- Cost post debridement in the first hospitalization [Срок оценки: Perioperative]
- Number of unplanned re-admissions [Срок оценки: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
- Number of unplanned operations [Срок оценки: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
- Number of percutaneous drainage after debridement [Срок оценки: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
- Antibiotic use after treatment [Срок оценки: Perioperative]
- Abdominal lavage [Срок оценки: Perioperative]
- Life quality one year after treatment [Срок оценки: Within one year after the last subject was treated]
Критерии участия
Критерии включения
- Age between 18 and 75 years.
- Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
- Patients undergoing open debridement for infected pancreatic necrosis
Критерии исключения
- Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).
- Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.
- Patients with pre-existing hematological diseases prior to AP.
- Patients undergoing laparoscopic or nephroscopic debridement.
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
Китай · 1 центр
- First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
Идентификаторы
NCT: NCT07080697 · IIT20250028C