05 Nov Managing Infected paNcreatic necrosIS in cHina：a register-based study

Posted at 17:24h in Clinical Trials by

 

Project abbreviation: Minish research

start date: 01/01/2020

end date: 01/01/2025

Recruitment start date: 01/01/2021

 

Background and Objective

infected pancreatic necrosis is the most important risk factor contributing to death in severe acute pancreatitis

Infected pancreatic necrosis (IPN) and its related septic complications are the major causes of death in patients with acute necrotizing pancreatitis(ANP)1.When compared with patients with sterile necrosis, patients with IPN suffered substantial increase in mortality ranging from 14% to 69% due to sepsis and its related multiple organ failure, despite advances in critical care, surgical interventions and antibiotics2. Necrotizing pancreatitis patients with IPN are more than twice as likely to die compared with those who without infected2, 3.

There is great heterogeneity on management of infected pancreatic necrosis

In clinical practice, infected necrosis is diagnosed by gas in the necrotic collection on imaging, positive culture of a fine-needle aspiration (FNA),or unequivocal clinical signs of infection4.There is still much controversial debate over treatment of IPN. The first issue that needs to be considered is the antimicrobial therapy. The guidelines recommend that antibiotics be given if infection is suspected or identified. GARG et al. concluded that primary conservative strategy including antibiotics application resulted in mortality that was comparable with surgery strategy; surgery interventions could be avoided in almost half of IPN patients5. Another issue worth discussing is the timing of intervention in patients with IPN. Postponing all interventions for infected necrosis until the stage of walled-off necrosis has been standard practice for many years. However, in some particular conditions, this strategy may bring some additional risks, such as Candida infections, antibiotic resistance and further clinical deterioration. Other issues included but not the least, optimization of minimally-invasive operative technology, step-up approach consisting of percutaneous drainage or endoscopic transmural drainage compared open surgery in selected patients. From the results of our national survey in china, there is a significant variation in the management strategies of IPN between different centers or even within centers.

The rationale for conducting this study

IPN is a heterogeneous severe complication in necrotizing pancreatitis with marked variation in extent and course. The management of IPN is varies widely, notably, the threapeutic effect would be significantly different dispite so many practical guidelines and standard threatment intrducted to clinicians. Nevertheless, from the previous publications review, the national data from a large population, vast territory, uneven development, a multi-regional and multi-ethnic country such as china, on the management of IPN is scarce. To this end, we conducted a survey study. The results highlight significant variation in practical cognition between Chinese clinicians while also demonstrating the significant uptake of the ‘step-up’ approach6, which has been shown in other studies to be associated with a significantly reduced requirement for open surgical treatment and improved outcomes. Dose the same phenomenon exist in clinical data in the real world is unknown, but it’s an interesting and valuable issue worth exploring. This study presents the design of a register-based research on the management of IPN in china.

 

Aims and hypotheses

We aimed to investigate the current management and prognosis information of IPN in major clinical centers of china, in order to understand the current status of IPN treatment, analyze the impact of different management schemes on prognosis.

General study setting

The present clinical observation register study will be performed in 20 different centers of pancreatitis across China. It is an register-based, prospect, multi-centered study.

Primary outcome

All patients will be followed until hospital death or discharge. The primary endpoint was a composite of major complications and/or death. Major complications included new onset organ failure based on the modified Marshall’s score including respiratory, renal and cardiovascular, gastrointestinal perforation or fistula requiring surgery, bleeding requiring bedside packing, transarterial embolization or emergency surgery.

Population

We are going recruit approximately 300 patients presenting to the participating centers across China into the study from the over a five-year period. Based on the volume of all the participating centers, the aim should be able to be achieved within the study period.

Inclusion Criteria

  1. Informed consent form obtained from the patient or next of kin;
  2. Age between 18 to 70 years old;
  3. Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography or less commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography according to the Revised Atlanta Criteria;
  4. Infected necrosis is diagnosed by gas in the necrotic collection on imaging, positive culture of a fine-needle aspiration (FNA), or unequivocal clinical signs of infection.

Exclusion Criteria

  1. Pregnant pancreatitis;
  2. Receiving intervention or early surgery due to abdominal compartment syndrome or other reasons before admission ;
  3. Patients with a known history of severe cardiovascular, respiratory, renal, hepatic, hematologic, or immunologic disease defined as (1) greater than New York Heart Association class II heart failure, (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days, (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen
  4. Patients with preexisting immune disorders such as AIDS.

 

 

References

  1. Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA 2021;325(4): 382-390.
  2. Werge M, Novovic S, Schmidt PN, Gluud LL. Infection increases mortality in necrotizing pancreatitis: A systematic review and meta-analysis. Pancreatology 2016;16(5): 698-707.
  3. Petrov MS, Shanbhag S, Chakraborty M, et al. Organ failure and infection of pancreatic necrosis as determinants of mortality in patients with acute pancreatitis. Gastroenterology 2010;139(3): 813-820.
  4. van Grinsven J, van Santvoort HC, Boermeester MA, et al. Timing of catheter drainage in infected necrotizing pancreatitis. Nat Rev Gastroenterol Hepatol 2016;13(5): 306-312.
  5. Garg PK, Sharma M, Madan K, et al. Primary conservative treatment results in mortality comparable to surgery in patients with infected pancreatic necrosis. Clin Gastroenterol Hepatol 2010;8(12): 1089-1094 e1082.
  6. van Dijk SM, Hallensleben NDL, van Santvoort HC, et al. Acute pancreatitis: recent advances through randomised trials. Gut 2017;66(11): 2024-2032.