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CompletedNCT03890328Updated Mar 26, 2019

RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.

An interventional study of radiofrequency ablation in Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis, sponsored by Southwest Hospital, China. Completed at 1 site in China. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 years after the study started (first participant enrolled Mar 2009, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Non-randomized
Ages
Up to 70 Years
Sex
All
01

Study summary

Radiofrequency (RF) can be used to treat splenic trauma because of its excellent coagulation hemostasis. This study aimed to compare the efficacy of RF-assisted spleen-preserving surgery with that of conventional splenorrhaphy/splenectomy in the treatment of blunt splenic injury.

A total of 122 patients with splenic trauma admitted to two tertiary referral centers from June 2011 to June 2014 were included in this prospective cohort study. The 67 patients at one center were treated by radiofrequency-assisted spleen-preserving therapy (RF group), and the 55 patients admitted at the other center underwent conventional treatment (CT group). Demographics and clinical characteristics of the two groups were comparable.

Compared to traditional splenorrhaphy and splenectomy, RF-assisted splenic hemostasis and salvage was safe, effective and easy to use in the treatment of splenic injuries. In particular for high-grade splenic injuries, these techniques preserved sufficient splenic tissue without any increase in patients with surgical risk.

02

Conditions studied

  • Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis
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In context

Lead sponsor

Southwest Hospital, China is the lead sponsor of 87 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. age below 70
  2. blunt abdominal injury combined with indication of post-traumatic splenectomy according to the guidelines provided by the Society for Surgery of the Alimentary Tract in 2005
  3. patients transferred directly to the trauma center after injury who had not been treated by any specific spleen-directed therapy in the transferring hospital
  4. AAST grade II splenic injury with hemodynamic instability or progressive bleeding requiring active intervention
  5. AAST grade Ⅲ-Ⅳsplenic injury, or splenic laceration involving less than 50% of the splenic parenchyma

Exclusion criteria

Exclusion Criteria:

  1. penetrating abdominal injury
  2. concomitant organ injury with an abbreviated injury scale (AIS) greater than 4 that threatened the life of the patient
  3. excessive vascular injury to the splenic pedicle or substantial devitalized splenic tissues when it was expected in when less than 25% of the spleen could be preserved
  4. patients who had failed NOM
  5. patients with pathologic splenic rupture
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    RF group

    radiofrequency-assisted spleen-preserving therapy group.

    Procedure: radiofrequency ablation

  • No intervention
    CT group

    Conventional Treatment of Blunt Splenic Injury group.

Interventions

  • Procedureradiofrequency ablation

    apply RF therapy to the treatment of splenic trauma

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What researchers measure

Primary outcomes

  1. Mean operative time，

    Mean operative time of the RF group was compared with that of CT group.

    Time frame: intraoperative

  2. intraoperative bleeding

    Intraoperative bleeding of the RF group was compared with that of CT group.

    Time frame: intraoperative

07

Study locations

1 site
  • Institute of hepatobiliary surgery,Southwest Hospital
    Chongqing, Chongqing Municipality 400038, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03890328
Lead sponsor
Southwest Hospital, China
Collaborators
West China Second University Hospital
Responsible party
fengkai (associate professor, Southwest Hospital, China) — Principal investigator
First posted
Mar 26, 2019
Start date
Mar 1, 2009
Primary completion
Jun 1, 2014
Completion
Jun 1, 2014
Last update
Mar 26, 2019

Study contacts

Kuansheng Ma, Ph.D
principal investigator · Institute of hepatobiliary surgery,Southwest Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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