Stomach Neoplasm
Conditions
Brief summary
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.
Interventions
PROCEDUREGroup1
Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
PROCEDUREGroup2
Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
PROCEDUREGroup3
No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Sponsors
Gangnam Severance Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery 2. Patients aged between 20 to 80 3. Patients with an ECOG 0 or 1 4. Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery
Exclusion criteria
1. Patients with abnormal liver function test befor surgery 2. Patients who diagnosed liver cirrhosis or infectious liver disease 3. Patients who underwent liver resection, or chemotherapy for gastric cancer 4. Patients planned for combined liver resection or cholecystectomy during gastrectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging | Real time near-infrared fluorescence image will be obtained during the surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT) | Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day. | 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. |
Countries
South Korea
Outcome results
None listed