NCT03681041

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
18.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

23 years

First QC Date

September 13, 2018

Last Update Submit

September 21, 2022

Conditions

Trauma

Keywords

Pancreatic injury

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    All cause mortality within 30 days

    30 days

Secondary Outcomes (12)

  • 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

    30 days

  • Systematic complication

    30 days

  • Operational intervention

    30 days

  • +7 more secondary outcomes

Study Arms (1)

Pancreatic injury

Patient diagnosed with pancreatic trauma by surgery, computed tomography, Endoscopic retrograde cholangiopancreatography (ERCP) and Magnetic resonance cholangiopancreatography (MRCP) were included

Other: Standard treatment

Interventions

Standard treatmentOTHER

Treatment according to guidelines for pancreatic trauma according to the Chinese Trauma Association and the American Association for the Surgery of Trauma

Pancreatic injury

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who were treated for pancreatic injuries at the Trauma Centres

You may qualify if:

  • Patient diagnosed with pancreatic trauma by surgery
  • computed tomography
  • Endoscopic retrograde cholangiopancreatography (ERCP)
  • Magnetic resonance cholangiopancreatography (MRCP)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (1)

  • Wang K, Li K, Deng Y, Wang X, Yang C, Chu C, Li W, Li J, Ding W. Postoperative hemorrhage following pancreatic injury: Risk factors and clinical outcomes. J Hepatobiliary Pancreat Sci. 2023 May;30(5):644-654. doi: 10.1002/jhbp.1251. Epub 2022 Nov 3.

    PMID: 36270802DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples analyses are performed by dedicated research center: 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 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.

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

025-80863337dr_kaiwang@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 21, 2018

Study Start

January 1, 2000

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)