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

Completed

• Conditions: Acute Pancreatitis
• Interventions: Procedure: The novel PMMI surgical strategy; Procedure: The conventional step-up strategy

• Registration Number: NCT06241586
• Lead Sponsor: Tianjin Nankai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-10-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-28
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the early period group	The novel PMMI surgical strategy	Patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies.
the early period group	The conventional step-up strategy	Patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies.
the late period group	The novel PMMI surgical strategy	Patients admitted during and after January 2021 received the complete novel PMMI surgical strategy.

Primary Outcome Measures

Name	Time	Method
major complications	90-day follow up

Secondary Outcome Measures

Name	Time	Method
mortality	90-day follow up
Admission of ICU	up to 90-days
individual major complications	90-day follow up	The 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).
Length of hospital stay	up to 90-days

Trial Locations

Locations (1)

Tianjin NanKai Hospital; 🇨🇳 Tianjin, None Selected, China