Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • beyond D2 regional lymph node dissection

    Procedure/Surgery

    dissect the lymph nodes outside the extent of D2 LN region.

Treatment groups

760 Participants
are divided into 2 treatment groups
Group A: laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group1 intervention
Group B: laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group1 intervention

Trial outcomes

Primary outcomes

1

3-year disease free survival rate

Disease-free survival is calculated from the day of surgery to the day of recurrence or death

Time frame
3 years

Secondary outcomes

1

Total number of retrieved lymph nodes

Total number of retrieved lymph nodes

Time frame
30 days
2

Noncompliance rate of lymph node dissection

The LN dissection rate was determined by the number of patients in whom a LN station was harvested divided by the total number of patients who required retrieval at the corresponding LN station. Within the scope of D2 dissection, LN noncompliance was defined as the absence of LNs that should have been resected from \> 1 LN station.

Time frame
30 days
3

Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A

Relationship between the number of fluorescent lymph nodes in group A and total number of lymph nodes in group A

Time frame
30 days
4

Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)

The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (True positive rate).

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.