Clinical trial NCT03681041: Pancreatic Injury and Corresponding Management Outcome (PICO)
Official title: Pancreatic Injury and Corresponding Management Outcome (PICO): Prospective Multicenter Cohort Study From the Tertiary Referral or University-affiliated Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Keywords: Pancreatic injury
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who were treated for pancreatic injuries at the Trauma Centres

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.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with pancreatic trauma by surgery
* computed tomography
* Endoscopic retrograde cholangiopancreatography (ERCP)
* Magnetic resonance cholangiopancreatography (MRCP)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: pancreatic associated complications
timeFrame: Through study completion, an average of 1 year
measure: Non-pancreatic associated complications
timeFrame: Through study completion, an average of 1 year
measure: Organ failure
timeFrame: 30 days
measure: Systematic complication
timeFrame: 30 days
measure: Operational intervention
timeFrame: 30 days
measure: Days on total parenteral nutrition
timeFrame: Through study completion, an average of 6 months
measure: Time to enteral nutrition
timeFrame: Through study completion, an average of 6 months
measure: Days to clear liquids
timeFrame: Through study completion, an average of 6 months
measure: Days to regular diet
timeFrame: Through study completion, an average of 6 months
measure: Postoperative 30-day adverse effects
timeFrame: 30 day
measure: Hospital length of stay
timeFrame: Through study completion, an average of 6 months
measure: Intensive Care Unit length of stay
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Medical School of Nanjing University
name: Weiwei Ding, MD
role: STUDY_DIRECTOR
References:
citation: Wang K, Li K, Deng Y, Wang X, Yang C, Chu C, Li W, Li J, Ding W. Postoperative hemorrhage following pancreatic injury: Risk factors and clinical outcomes. J Hepatobiliary Pancreat Sci. 2023 May;30(5):644-654. doi: 10.1002/jhbp.1251. Epub 2022 Nov 3.