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

NCT04335474 | Unknown DMC

• 1 other identifier: 2019NZKY-079-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Pancreatic Trauma

Keywords

High-grade pancreatic trauma; Management strategy

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  All cause mortality within 28 days

  28 days

Secondary Outcomes (11)

• Pancreatic associated complications

  Through study completion, an average of 1 year

• Non-pancreatic associated complications

  Through study completion, an average of 1 year

• Organ failure

  28 days

• Systematic complication

  28 days

• Days on total parenteral nutrition

  Through study completion, an average of 6 months]

Study Arms (2)

Surgical drainage

Cases that have surgical management

Procedure: Surgical drainage strategy

Percutaneous drainage

Cases that have the nonoperative management by percutaneous drainage

Procedure: Percutaneous drainage strategy

Interventions

Surgical drainage strategy PROCEDURE

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.

Surgical drainage

Percutaneous drainage strategy PROCEDURE

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.

Percutaneous drainage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who treated for High-grade pancreatic injuries at a national Level 1 trauma center

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing PLA General Hospital: lead

Study Sites (1)

Jinling Hospital

Nanjing, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples analyses are performed by dedicated research centers: DNA, and RNA extraction for transcriptome analysis, histological analyzes, etc: 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.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Weiwei Ding, MD

  Medical School of Nanjing University

  STUDY DIRECTOR

Central Study Contacts

Kai Wang, MD

CONTACT

025-80863337; dr_kaiwang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)