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临床试验/NCT07097753
NCT07097753Enrolling By Invitation不适用

A Retrospective Cohort Before-After Study Comparing the Prognostic Outcomes of MIPPED-C With Open Surgical Necrosectomy in Infected Pancreatic Necrosis

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
144
试验地点
1
主要终点
all-cause mortality

研究概览

简要总结

This study is a retrospective, single-center, pre-post controlled clinical study. Patients (n=48) who underwent the MIPPED-C surgical procedure after January 1, 2019 were designated as the treatment group. Patients who were admitted to the hospital from January 1, 2014 to December 31, 2018 and underwent traditional open surgery were retrospectively evaluated by surgeons, radiologists, and interventionalists, and then matched for propensity score with a 1:2 ratio. 96 patients who underwent traditional open surgery were selected as the control group. The treatment group underwent the MIPPED-C surgery, while the control group underwent the traditional open necrotic tissue debridement procedure. The differences in inflammatory indicators, SIRS response, immune indicators, organ function indicators, and imaging changes of the two groups of patients at the time of admission, before the operation, and after the operation were retrospectively collected. The survival status, postoperative complications, re-intervention status, hospital stay, ICU stay, and hospitalization costs of the two groups of patients after the operation were also collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) age ≥18 years; (2) a confirmed diagnosis of infected pancreatic necrosis (IPN) based on imaging (e.g., presence of gas within necrosis) and clinical indicators (e.g., fever, leukocytosis, or positive cultures); (3) underwent either the MIPPED-C procedure or OSN as the definitive surgical intervention; and (4) had a minimum follow-up period of 90 days postoperatively.

排除标准

  • (1) non-infected pancreatic necrosis; (2) receipt of interventions other than MIPPED-C or OSN (e.g., endoscopic or purely percutaneous approaches); (3) prior history of IPN surgery or other major abdominal surgery that could confound surgical outcomes; or (4) incomplete follow-up data or loss to follow-up within 90 days after surgery.

结局指标

主要结局

all-cause mortality

时间窗: Half a year after the surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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