Pancreatic Injury and Corresponding Management Outcome (PICO)

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03681041
• Other study ID #: 2021DZGZR-YBB-009
• Status: Recruiting
• Start date: January 1, 2000
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2022
• Source: Nanjing PLA General Hospital
• Contact: Kai Wang, MD
• Phone: 025-80863337
• Email: dr_kaiwang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma

Intervention

Other:
• Standard treatment
Treatment according to guidelines for pancreatic trauma according to the Chinese Trauma Association and the American Association for the Surgery of Trauma

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	All cause mortality within 30 days	30 days
Secondary	pancreatic associated complications	Complications due to pancreatic problems	Through study completion, an average of 1 year
Secondary	Non-pancreatic associated complications	Abdominal complications of non-pancreatic problems	Through study completion, an average of 1 year
Secondary	Organ failure	Organ failure caused by organ dysfunction	30 days
Secondary	Systematic complication	Complications such as pneumonia, abdominal sepsis, etc	30 days
Secondary	Operational intervention	Complications after treatment for patients require operational intervention	30 days
Secondary	Days on total parenteral nutrition	Treatment time of parenteral nutrition support required during hospitalization	Through study completion, an average of 6 months
Secondary	Time to enteral nutrition	Time from management to initiate enteral nutrition in pancreatic injury patients	Through study completion, an average of 6 months
Secondary	Days to clear liquids	The time when the drainage tube is pulled out after the patient's abdominal liquids cleated	Through study completion, an average of 6 months
Secondary	Days to regular diet	The time from the treatment to the normal eating of patients with pancreatic trauma	Through study completion, an average of 6 months
Secondary	Postoperative 30-day adverse effects	All cause adverse effects within 30 days	30 day
Secondary	Hospital length of stay	Length of hospital stay	Through study completion, an average of 6 months
Secondary	Intensive Care Unit length of stay	Length of Intensive Care Unit stay	Through study completion, an average of 6 months