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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Procedure: The novel PMMI surgical strategy; Procedure: The conventional step-up strategy

• Study Type: Observational
• Enrollment (Actual): 271

Contacts and Locations

Study Locations

• China
  • None Selected
    • Tianjin, None Selected, China
      • Tianjin Nankai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

We conducted a retrospective, before-after, single-center study from January 2019 to September 2022 at the Department of Surgery, Tianjin Nankai Hospital. Consecutive patients older than 18 years with necrotizing pancreatitis were included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the early period group; Patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies.	Procedure: The 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.; Procedure: The 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.
the late period group; Patients admitted during and after January 2021 received the complete novel PMMI surgical strategy.	Procedure: The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
major complications	90-day follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		90-day follow up
Admission of ICU		up to 90-days
Length of hospital stay		up to 90-days
individual major complications	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).	90-day follow up

Collaborators and Investigators

• Sponsor: Tianjin Nankai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: TianjinNH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No