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A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis

A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis: A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06241586
Enrollment
271
Registered
2024-02-05
Start date
2019-01-01
Completion date
2022-10-01
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Brief summary

The goal of this observational study is to compare patient outcomes between the groups of patients admitted before and after the full implementation of the novel surgical strategy in patients with necrotizing pancreatitis. The main question it aims to answer are: • the efficacy and safety of the novel surgical strategy To assess the efficacy and safety of the novel surgical strategy, all included patients were divided into two groups according to the timing of receiving treatment: 1) the early period group: patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies; and 2) the late period group: patients admitted during and after January 2021 received the complete novel surgical strategy.

Interventions

PROCEDUREThe novel PMMI surgical strategy

Immediate drainagewas advocated within 24 hours once necrosis was diagnosed. During the treatment course, a hybrid approach was available by flexibly switching interventions. Open surgery was only applied when patients required emergency surgery. The minimally invasive surgery was selected based on the size, location, and maturity of the necrotic area and stepwise response to intervention. Repeated peritoneal purification was performed until the infected or devitalized tissue was controlled. Patients were subsequently discharged with a drainage catheter and readmitted at 7- to 10-day intervals to receive repeated planned surgery without postoperative irrigation. Patients received a whole-course assessment for individual patients at 7-day predetermined intervals.

PROCEDUREThe conventional step-up strategy

Interventions were postponed until 4 weeks after the onset of pancreatitis in line with international guidelines unless the patient showed evidence of progressive clinical deterioration despite the use of maximal supportive care. Patients underwent CT-guided percutaneous catheter drainage as the first step. Treatment response was evaluated after 3 days. If drainage was clinically unsuccessful, a VARD procedure was performed. Similarly, open surgery, which was described by Beger et al., was performed if the VARD procedure failed. Postoperative continuous lavage is performed as a routine procedure.

Sponsors

Tianjin Nankai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

Consecutive patients older than 18 years with necrotizing pancreatitis were included.

Exclusion criteria

Patients who met one or more of the following criteria were excluded: (1) had a past medical history of acute pancreatitis; (2) had drainage or surgery for pancreatic necrosis in other hospitals before admission to our institute; and (3) did not complete the treatment strategy owing to nonmedical reasons.

Design outcomes

Primary

MeasureTime frame
major complications90-day follow up

Secondary

MeasureTime frameDescription
mortality90-day follow up
Admission of ICUup to 90-days
Length of hospital stayup to 90-days
individual major complications90-day follow upThe overall complications included procedure-related complications (intra-abdominal and gastrointestinal bleeding, pancreatic fistulas, and gastrointestinal perforation) and nonspecific complications (systemic inflammatory response syndrome, abdominal compartment syndrome, and new-onset renal, respiratory and circulatory failure).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026