An interventional study of Group1 and Group2 in Stomach Neoplasm, sponsored by Gangnam Severance Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Diagnostic
" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.
There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.
This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 50 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
Procedure: Group1
Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Procedure: Group2
No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Procedure: Group3
Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging. The order of the algorithm is as follows: First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed. After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging. The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.
Time frame: Real time near-infrared fluorescence image will be obtained during the surgery.
Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)
The elevated proprtion of the serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) compared to preoperative value will be calculated and compared by groups.
Time frame: Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Gangnam Severance Hospital