NCT05369117

Brief Summary

Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,016

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
12mo left

Started May 2022

Longer than P75 for not_applicable gastric-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
May 2022May 2027

First Submitted

Initial submission to the registry

April 25, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2027

Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

4.9 years

First QC Date

April 25, 2022

Last Update Submit

May 26, 2022

Conditions

Gastric Cancer

Keywords

Indocyanine green

Outcome Measures

Primary Outcomes (1)

  • Three-year disease-free survival rate

    To evaluate the difference of 3-year disease-free survival rate between the experimental group and the control group

    Through study completion，an average of 3 years

Secondary Outcomes (3)

  • lymph node positive rate

    up to 1 week

  • Incidence of early complications

    up to 1 week

  • operative mortality

    up to 24 hours

Study Arms (2)

indocyanine green labeled fluorescent laparoscopy

EXPERIMENTAL

The experimental group was marked with indocyanine green, while the control group was not marked with indocyanine green

Behavioral: indocyanine green labeled fluorescent laparoscopy

The pathological staging

EXPERIMENTAL

They were grouped by different pathological stages

Behavioral: indocyanine green labeled fluorescent laparoscopy

Interventions

indocyanine green labeled fluorescent laparoscopyBEHAVIORAL

indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery

The pathological stagingindocyanine green labeled fluorescent laparoscopy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old \< age \< 75 years old
  • The primary gastric lesion was pathologically diagnosed as proximal gastric adenocarcinoma by endoscopic biopsy (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR)
  • Preoperative clinical staging was CT1-4A, N-/+, and M0, according to AJCC-8th TNM tumor staging
  • No distant metastasis was found in preoperative examination, and the tumor did not directly invade pancreas, spleen or other adjacent organs
  • ECOG physical status score 0/1 before surgery Preoperative ASA score I-III
  • (7) Informed consent of patients

You may not qualify if:

  • Suffering from severe mental illness
  • Severe complications cannot tolerate surgery
  • Simultaneous surgical treatment of other diseases is required
  • History of gastric surgery (including ESD/EMR for gastric cancer)
  • Tumors involving esophagus or duodenum were confirmed preoperatively
  • Neoadjuvant therapy has been implemented
  • Leather stomach
  • Refusing laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of General Surgery department

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 11, 2022

Study Start

May 31, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 6, 2027

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share