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

NCT06241586 | Completed DMC

• 1 other identifier: TianjinNH
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• major complications

  90-day follow up

Secondary Outcomes (4)

• mortality

  90-day follow up

• Admission of ICU

  up to 90-days

• Length of hospital stay

  up to 90-days

• individual major complications

  90-day follow up

Study Arms (2)

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; Procedure: The conventional step-up strategy

the late period group

Patients admitted during and after January 2021 received the complete novel PMMI surgical strategy.

Procedure: The novel PMMI surgical strategy

Interventions

The novel PMMI surgical strategy PROCEDURE

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.

the early period group; the late period group

The conventional step-up strategy PROCEDURE

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 early period group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (1)

Tianjin NanKai Hospital

Tianjin, None Selected, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physicians

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: October 1, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)