Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Stomach Neoplasm

Treatments: Procedure: Group3; Procedure: Group1; Procedure: Group2

Study type: Interventional

Funder types: Other

Identifiers

NCT05971069

3-2021-0376

Details and patient eligibility

About

" 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. "

Enrollment: 50 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Group1

Experimental group

Description:

Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery

Treatment:

Procedure: Group1

Group2

Experimental group

Description:

Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Treatment:

Procedure: Group2

Group3

Experimental group

Description:

No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Treatment:

Procedure: Group3