Acute Pancreatitis (AP)NCT07097753
Comparison of MIPPED-C and Surgical Necrosectomy in Pancreatic Necrosis Outcomes
An observational study of Acute Pancreatitis (AP) and Acute Pancreatitis With Infected Necrosis, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis (AP), Acute Pancreatitis With Infected Necrosis
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Emergency Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
About this study
Official title: A Retrospective Cohort Before-After Study Comparing the Prognostic Outcomes of MIPPED-C With Open Surgical Necrosectomy in Infected Pancreatic Necrosis
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.
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open surgical debridement of necrotic tissue | Not described | |
| Minimally Invasive Partitioned Pancreatic Debridement and Enhanced Cross-Drainage | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: Half a year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097753
- Sponsor's protocol ID
- 20250529075134604
- Status last verified
- May 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Before-After Study Comparing the Prognostic Outcomes of MIPPED-C With Open Surgical Necrosectomy in Infected Pancreatic Necrosis
- ClinicalTrials.gov ID
- NCT07097753
- Acronym / sponsor ID
- 20250529075134604
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgical debridement of necrotic tissue | – | – |
| Minimally Invasive Partitioned Pancreatic Debridement and Enhanced Cross-Drainage | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause mortality
Time frame: Half a year after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis (AP) and Acute Pancreatitis With Infected Necrosis, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: Half a year after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.