Clinical trial NCT04335474: Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma
Official title: Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma: A Prospective Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Pancreatic Trauma
Keywords: High-grade pancreatic trauma
Management strategy
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 80
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 treated for High-grade pancreatic injuries at a national Level 1 trauma center

Brief summary: High-grade pancreatic injury is rare, and the reported complication and mortality are high.

The optimal management strategy according to high-grade injuries remains controversial.

The present study compares surgical drainage with percutaneous drainage in the management of High-grade pancreatic trauma.

Detailed description: High-grade pancreatic trauma (HGPT), while uncommon, presents challenging diagnostic and therapeutic dilemmas to trauma surgeons. Multiple management strategies to HGPT have been reported, which was associated with a high level of morbidity and mortality rate. Besides, few prospective studies have investigated the optimal management strategy of patients with HGPT.

We aimed to compare surgical drainage with percutaneous drainage in the management of HGPT. 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 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 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 a usual practice, post-operative treatment will be prescribed at the investigator's discretion, with the help of an acre-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, treatment history, post-operative treatment if prescribed, treatment history between surgery and image logical diagnosis are recorded. Clinical data are also collected 12months after discharge during a scheduled visit organized as usual practice, for long-term study.

Several studies will be performed along with the cohort setting-up:

* Comparison of the diagnosis time and treatment time of patients with HGPT
* Study of surgical methods and intraoperative conditions in patients with HGPT
* Study of ICU resuscitation treatment of patients with HGPT
* Study of complication, ICU length of stay and hospital length of stay for patients with HGPT
* Study of nutritional support treatment for patients with HGPT
* Study of mortality and cost for patients with HGPT

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 centers: 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 byHuman 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 high-grade pancreatic trauma by surgery
* Patient diagnosed with high-grade pancreatic trauma by computed tomography
* Patient diagnosed with high-grade pancreatic trauma by Endoscopic retrograde cholangiopancreatography (ERCP)
* Patient diagnosed with high-grade pancreatic trauma by Magnetic resonance cholangiopancreatography (MRCP)

Exclusion Criteria:

* The patient underwent chemotherapies or radiotherapy
* Immune system disease
* Low-grade pancreatic trauma
* Accompanied by severe trauma to other organs
* End-stage chronic organ failure
* With multiple severe injuries
* Died within 24 h of admission
* Younger than 18 years
* Pregnant

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 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: 28 days
measure: Systematic complication
timeFrame: 28 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 28-day adverse effects
timeFrame: 28 days
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
Study officials:
affiliation: Medical School of Nanjing University
name: Weiwei Ding, MD
role: STUDY_DIRECTOR
References: