TraumaNCT04335474
Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma
An observational study of Trauma and Pancreatic Trauma, run by Nanjing PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trauma, Pancreatic Trauma
- What is being tested?
- Surgical drainage strategy and Percutaneous drainage strategy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who treated for High-grade pancreatic injuries at a national Level 1 trauma center
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Died within 24 h of admission
- Younger than 18 years
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, 210000
Jieshou Li, MD, 025-80860037, njlijieshou@126.com
About this study
Official title: Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma: A Prospective Controlled Study
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.
Read the 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.
- Conditions
- Trauma, Pancreatic Trauma
- Being tested
- Surgical drainage strategy, Percutaneous drainage strategy
- Keywords
- High-grade pancreatic trauma, Management strategy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical drainage strategyProcedure or surgery
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 strategyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical drainage | Cases that have surgical management Receives: Procedure: Surgical drainage strategy | |
| Percutaneous drainage | Cases that have the nonoperative management by percutaneous drainage Receives: Procedure: Percutaneous drainage strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
All cause mortality within 28 days
Measured: 28 days
Secondary outcomes (11)
Pancreatic associated complications
Complications due to pancreatic problems
Measured: Through study completion, an average of 1 year
Non-pancreatic associated complications
Abdominal complications of non-pancreatic problems
Measured: Through study completion, an average of 1 year
Organ failure
Organ failure caused by organ dysfunction
Measured: 28 days
Systematic complication
Complications such as pneumonia, abdominal sepsis, etc
Measured: 28 days
Days on total parenteral nutrition
Treatment time of parenteral nutrition support required during hospitalization
Measured: Through study completion, an average of 6 months]
Time to enteral nutrition
Time from management to initiate enteral nutrition in pancreatic injury patients
Measured: Through study completion, an average of 6 months
Days to clear liquids
The time when the drainage tube is pulled out after the patient's abdominal liquids cleated
Measured: Through study completion, an average of 6 months
Days to regular diet
The time from the treatment to the normal eating of patients with pancreatic trauma
Measured: Through study completion, an average of 6 months
Postoperative 28-day adverse effects
All cause adverse effects within 28 days
Measured: 28 days
Hospital length of stay
Length of hospital stay
Measured: Through study completion, an average of 6 months
Intensive Care Unit length of stay
Length of Intensive Care Unit stay
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Tao, Nanjing PLA General Hospital
- Investigators
- Weiwei Ding, MD, Study director, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335474
- Sponsor's protocol ID
- 2019NZKY-079-01
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT04335474
- Acronym / sponsor ID
- 2019NZKY-079-01
- Conditions
- Trauma, Pancreatic Trauma
- Keywords
- High-grade pancreatic trauma, Management strategy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical drainage | – | Procedure: Surgical drainage strategyCases that have surgical management |
| Percutaneous drainage | – | Procedure: Percutaneous drainage strategyCases that have the nonoperative management by percutaneous drainage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who treated for High-grade pancreatic injuries at a national Level 1 trauma center
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical drainage strategyA 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. | Procedure or surgery | Surgical drainage |
| Percutaneous drainage strategyThe 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. | Procedure or surgery | Percutaneous drainage |
Primary outcome
28-day mortality
Time frame: 28 days
All cause mortality within 28 days
11 secondary outcomes
Pancreatic associated complications
Time frame: Through study completion, an average of 1 year
Non-pancreatic associated complications
Time frame: Through study completion, an average of 1 year
Organ failure
Time frame: 28 days
Systematic complication
Time frame: 28 days
Days on total parenteral nutrition
Time frame: Through study completion, an average of 6 months]
Time to enteral nutrition
Time frame: Through study completion, an average of 6 months
Days to clear liquids
Time frame: Through study completion, an average of 6 months
Days to regular diet
Time frame: Through study completion, an average of 6 months
Postoperative 28-day adverse effects
Time frame: 28 days
Hospital length of stay
Time frame: Through study completion, an average of 6 months
Intensive Care Unit length of stay
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiwei Ding, MD study director
Medical School of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Pancreatic Trauma, run by Nanjing PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, MD (025-80863337, dr_kaiwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.