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Enrolling by Invitation

NCT Number: NCT07097753

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. all-cause mortality

    Time frame: Half a year after the surgery

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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