Study type: Human research · Status: Verified against declared source
Thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis (TRACE trial): protocol of a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial
2020
Study scale: This study was approved by the ethics committee of Jinling Hospital, Nanjing University (Number 2015NZKY-004-02).
Abstract only: Open source record
Product or molecular entity relationships
- Thymosin Alpha 1: Exact entity relationship. Legacy citation custody associates this source with the catalog record; no product-relevance conclusion is implied.
Plain-language verified summary
Question
Infected pancreatic necrosis (IPN) and its related septic complications contribute substantially to deaths in patients with acute necrotising pancreatitis(ANP).1 Compared with patients with sterile necrosis, those with IPN suffered a significant increase in mortality ranging from 14% to 69%, despite advances in critical care, surgical and endoscopic interventions and antibiotics.2 Therefore, the prevention of IPN is of great clinical value in the treatment of ANP.
Methods
Infected pancreatic necrosis (IPN) and its related septic complications are the major causes of death in patients with acute necrotising pancreatitis (ANP).
Scale or participants
This study was approved by the ethics committee of Jinling Hospital, Nanjing University (Number 2015NZKY-004-02).
Key findings
Infected pancreatic necrosis (IPN) and its related septic complications are the major causes of death in patients with acute necrotising pancreatitis (ANP).
Limitations and uncertainty
A sample size of 520 is required to detect the efficacy of thymosin alpha 1 in preventing infected pancreatic necrosis, which will take years before the conclusion could be drawn.
Verified against declared source. Verification is limited to the declared source and review scope. It does not mean independent replication or establish efficacy, safety, or suitability.