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

NCT ID: NCT05971069

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-17

Study Completion Date

2023-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

" 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. "

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group1

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

Group Type EXPERIMENTAL

Group1

Intervention Type PROCEDURE

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

Group2

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

Group Type EXPERIMENTAL

Group2

Intervention Type PROCEDURE

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

Group3

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

Group Type EXPERIMENTAL

Group3

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group1

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

Intervention Type PROCEDURE

Group2

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

Intervention Type PROCEDURE

Group3

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

In Gyu Kwon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GangnamSeverance Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3-2021-0376

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.