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Enrolling by invitation NCT07097753

Comparison of MIPPED-C and Surgical Necrosectomy in Pancreatic Necrosis Outcomes

Observational Acute Pancreatitis (AP) Acute Pancreatitis With Infected Necrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Pancreatitis (AP), Acute Pancreatitis With Infected Necrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • all-cause mortality [Time frame: Half a year after the surgery]

Eligibility criteria

Inclusion Criteria:(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.

Exclusion Criteria:(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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Emergency Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School — Shanghai

Identifiers

NCT: NCT07097753 · 20250529075134604

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗