Pancreatic Injury and Corresponding Management Outcome (PICO)
- Conditions
- Trauma
- Interventions
- Other: Standard treatment
- Registration Number
- NCT03681041
- Lead Sponsor
- Nanjing PLA General Hospital
- Brief Summary
Pancreatic injury is a relatively rare and result in significant morbidity and mortality.
Estimates for the incidence of pancreatic injury range from 0.2-12% of abdominal traumas. Many factors, such as patient stability, the acuity of concomitant life-threatening injuries, and the need for damage control procedures must therefore be balanced when considering the proper approach to pancreatic injury management.
However, few prospective studies have investigated the perioperative management of patients with pancreatic trauma.
- Detailed Description
Pancreatic trauma, while uncommon, presents challenging diagnostic and therapeutic dilemmas to trauma surgeons. Indeed, injuries to the pancreas have been associated with reported morbidity rates approaching 45%.
The disease 's characterization at a specific therapeutic level will allow for a better management of patients treated. To do so, the strategy is to integrate precise prospective clinical records extensive clinical treatment data in a large cohort of patients.
All the clinical departments, participating in the study, include patients, with a tight collaboration between Trauma, Intensive Care and Surgery departments. Demographics and clinical parameters are collected in a database.
Once after the diagnosis is confirmed, the inclusion of patients is performed, before a scheduled hospital management, and after eligibility criteria checking, and consent form signature. During clinical management, several samples are collected: blood samples and surgical specimens. As usual practice, post-operative treatment will be prescribed at investigator's discretion, with help of a pre-established algorithm. Several samples are also collected during this exam (blood and biological tissue sample).
At the same time as these managements, clinical data regarding medical history, pre-hospital treatment history, surgical history, treatments history, post-operative treatment if prescribed, treatments history between surgery and imageological diagnosis are recorded. Clinical data are also collected 12 months after discharge during a scheduled visit organized as usual practice, for long-term study.
Several studies will be performed along the cohort setting-up:
* Comparison of operative and non-operative treatment of pancreatic trauma:
* Comparison of the diagnosis time and treatment time of patients with pancreatic trauma and whether or not the treatment is missed
* Study of specific treatment of patients with pancreatic trauma
* Study of surgical methods and intraoperative conditions in patients with pancreatic trauma
* Study of ICU resuscitation treatment of patients with pancreatic trauma
* Study of endoscopy and other conservative treatments for patients with pancreatic trauma
* Study of nutritional support treatment for patients with pancreatic trauma
* Study of treatment methods for damage control and non-damage control in patients with severe pancreatic trauma
All the biologic samples are stored on sites at -80°C, or at room temperature depending on the samples: Samples collected in tubes, are sent immediately, at room temperature, to the central pathology department in Jinling Hospital, Nanjing, China. All the other samples, stored at -80°C, are sent to the Research Institute of General Surgery, Medical School of Nanjing University, China.
Samples analyses are performed by dedicated research center: DNA, and RNA extraction for transcriptome analysis, histological analyzes, etc:
Histological analyzes: Analysis of the structure of the excised pancreas or intestinal tissue.
Molecular Biology: Whole genome expression analyses are performed using microarray and followed by Gene Ontology and clustering analyses.
Microbiota: Bacterial composition of the ileal mucosa-associated microbiota is analyzed at the time of surgery using 16S (MiSeq, Illumina) sequencing. The obtained sequences are analyzed using the Qiime pipeline to assess composition, alpha and beta diversity.
Immunology: Phenotype of immune cells: Immune cells are extracted from blood and fresh mucosal tissues. The phenotype of these cells is analyzed by cytometry.
Analysis of neutrophil extracellular traps:
The concentrations of cell-free DNA, cell-free nucleosomes, neutrophil elastase (NE) and myeloperoxidase (MPO) were measured in sera and plasma by Human Cell Death Detection ELISA or sandwich ELISA.
Pancreatic tissue was removed rapidly and divided into different parts for later analyses. One was used for confocal microscopy and one third was snap-frozen in liquid nitrogen for biochemical quantification of pancreatic myeloperoxidase (MPO), histone 3, and histone 4 levels, etc. One was fixed in formalin for histologic analysis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Patient diagnosed with pancreatic trauma by surgery
- computed tomography
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Magnetic resonance cholangiopancreatography (MRCP)
- The patient underwent chemotherapies or radiotherapy
- immune system disease
- end-stage chronic organ failure
- moribund cases with multiple severe injuries
- died within 24 h of admission
- younger than 18 years
- pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pancreatic injury Standard treatment Patient diagnosed with pancreatic trauma by surgery, computed tomography, Endoscopic retrograde cholangiopancreatography (ERCP) and Magnetic resonance cholangiopancreatography (MRCP) were included
- Primary Outcome Measures
Name Time Method 30-day mortality 30 days All cause mortality within 30 days
- Secondary Outcome Measures
Name Time Method Days to regular diet Through study completion, an average of 6 months The time from the treatment to the normal eating of patients with pancreatic trauma
Operational intervention 30 days Complications after treatment for patients require operational intervention
Postoperative 30-day adverse effects 30 day All cause adverse effects within 30 days
Systematic complication 30 days Complications such as pneumonia, abdominal sepsis, etc
Non-pancreatic associated complications Through study completion, an average of 1 year Abdominal complications of non-pancreatic problems
pancreatic associated complications Through study completion, an average of 1 year Complications due to pancreatic problems
Organ failure 30 days Organ failure caused by organ dysfunction
Time to enteral nutrition Through study completion, an average of 6 months Time from management to initiate enteral nutrition in pancreatic injury patients
Days on total parenteral nutrition Through study completion, an average of 6 months Treatment time of parenteral nutrition support required during hospitalization
Days to clear liquids Through study completion, an average of 6 months The time when the drainage tube is pulled out after the patient's abdominal liquids cleated
Hospital length of stay Through study completion, an average of 6 months Length of hospital stay
Intensive Care Unit length of stay Through study completion, an average of 6 months Length of Intensive Care Unit stay
Trial Locations
- Locations (1)
Jinling Hospital
🇨🇳Nanjing, Jiangsu, China