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Pancreatic Injury and Corresponding Management Outcome (PICO)

Pancreatic Injury and Corresponding Management Outcome (PICO): Prospective Multicenter Cohort Study From the Tertiary Referral or University-affiliated Hospitals

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03681041
Enrollment
200
Registered
2018-09-21
Start date
2000-01-01
Completion date
2023-03-31
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

Pancreatic injury

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.

Interventions

OTHERStandard treatment

Treatment according to guidelines for pancreatic trauma according to the Chinese Trauma Association and the American Association for the Surgery of Trauma

Sponsors

Nanjing PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
30-day mortality30 daysAll cause mortality within 30 days

Secondary

MeasureTime frameDescription
pancreatic associated complicationsThrough study completion, an average of 1 yearComplications due to pancreatic problems
Non-pancreatic associated complicationsThrough study completion, an average of 1 yearAbdominal complications of non-pancreatic problems
Organ failure30 daysOrgan failure caused by organ dysfunction
Systematic complication30 daysComplications such as pneumonia, abdominal sepsis, etc
Operational intervention30 daysComplications after treatment for patients require operational intervention
Days on total parenteral nutritionThrough study completion, an average of 6 monthsTreatment time of parenteral nutrition support required during hospitalization
Time to enteral nutritionThrough study completion, an average of 6 monthsTime from management to initiate enteral nutrition in pancreatic injury patients
Days to clear liquidsThrough study completion, an average of 6 monthsThe time when the drainage tube is pulled out after the patient's abdominal liquids cleated
Days to regular dietThrough study completion, an average of 6 monthsThe time from the treatment to the normal eating of patients with pancreatic trauma
Postoperative 30-day adverse effects30 dayAll cause adverse effects within 30 days
Hospital length of stayThrough study completion, an average of 6 monthsLength of hospital stay
Intensive Care Unit length of stayThrough study completion, an average of 6 monthsLength of Intensive Care Unit stay

Countries

China

Contacts

Primary ContactKai Wang, MD
dr_kaiwang@163.com025-80863337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026