Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma

Trauma Clinical Trial

Official title:

Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma: A Prospective Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335474
• Other study ID #: 2019NZKY-079-01
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2020
• 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• 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 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

Related Conditions & MeSH terms

• Pancreatic Trauma
• Trauma
• Wounds and Injuries

Intervention

Procedure:
• Surgical drainage strategy
A laparotomy is performed and the operative approach to pancreatic trauma can consist of laparotomy with drainage of the peripancreatic area, distal pancreatectomy with or without preservation of the spleen, Rouxen-Y pancreaticojejunostomy, and, more seldom, pancreaticoduodenectomy. The type of operation depends on the grade of the pancreatic lesion. Spleen-preserving surgery will be attempted to avoid the lifelong increased risk of infections after splenectomy. In case of trauma where multiple organs are involved and an acute laparotomy is performed, the damage control surgery must be applied and the pancreatic resection will be done as part of a staged surgery.
• Percutaneous drainage strategy
The nonoperative management consists of close monitoring of the patient's clinical condition; repeated radiological investigations such as CT, ultrasound, and MRCP; monitoring of the amylase and lipase levels, initiation of post-pyloric enteral nutrition and parenteral nutrition. In addition, ERCP with the placement of a stent in the damaged pancreatic duct is used as part of the non-operative approach. Besides, percutaneous catheter drainage (PCD) management including ultrasound or CT-guided drainage of abdominal and peripancreatic fluid collections and pancreatic pseudocysts is applied to the HGPT patient.

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing

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	28-day mortality	All cause mortality within 28 days	28 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	28 days
Secondary	Systematic complication	Complications such as pneumonia, abdominal sepsis, etc	28 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 28-day adverse effects	All cause adverse effects within 28 days	28 days
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