NCT07097753

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 31, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

July 24, 2025

Last Update Submit

July 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    Half a year after the surgery

Study Arms (2)

Open surgical debridement of necrotic tissue

Minimally Invasive Partitioned Pancreatic Debridement and Enhanced Cross-Drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent traditional pancreatic debridement surgery and MIPPED-C IPN at Ruijin Hospital, affiliated to Shanghai Jiao Tong University School of Medicine from January 1, 2014 to December 31, 2023

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

July 31, 2025

Record last verified: 2025-05

Locations