Application of Indocyanine Green Labeled Fluorescent Laparoscopy in Proximal Gastric Cancer

Sponsor

Guangyong Zhang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05369117

Collaborator

(none)

1,016

Enrollment

Arms

59.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Behavioral: indocyanine green labeled fluorescent laparoscopy	N/A

Detailed Description

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.By recruiting patients and signing informed consent, randomized control was used to divide patients into the experimental group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery) and the control group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery). In the experimental group, indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery. Lymph nodes and diseased stomach tissues were collected during operation. Postoperative assessment was made for ICU support, routine acid-suppressing therapy, prophylactic antibiotics, analgesia, and nausea suppression. The patients were followed up for 3 years. The primary outcome was 3-year disease-free survival, and the secondary outcome was lymph node positive rate, early complication rate and surgical mortality. The investigators plan to obtain more precise evidence-based medical evidence through this project.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1016 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

To Evaluate Whether the Clinical Efficacy of Laparoscopic Lymph Node Dissection With Indocyanine Green Tracer is Better Than Without Indocyanine Green Tracer

Anticipated Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

May 6, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: indocyanine green labeled fluorescent laparoscopy The experimental group was marked with indocyanine green, while the control group was not marked with indocyanine green	Behavioral: indocyanine green labeled fluorescent laparoscopy indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery
Experimental: The pathological staging They were grouped by different pathological stages	Behavioral: indocyanine green labeled fluorescent laparoscopy indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery

Arm

Intervention/Treatment

Experimental: indocyanine green labeled fluorescent laparoscopy

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

Behavioral: indocyanine green labeled fluorescent laparoscopy

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

Experimental: The pathological staging

They were grouped by different pathological stages

Behavioral: indocyanine green labeled fluorescent laparoscopy

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

Outcome Measures

Primary Outcome Measures

Three-year disease-free survival rate [Through study completion，an average of 3 years]
To evaluate the difference of 3-year disease-free survival rate between the experimental group and the control group

Secondary Outcome Measures

lymph node positive rate [up to 1 week]
To evaluate the difference oflymph node positive rate between the experimental group and the control group
Incidence of early complications [up to 1 week]
The incidence of lymphatic leakage, shock and gastric stump leakage were used as secondary outcome measures
operative mortality [up to 24 hours]
To investigate whether the mortality of laparoscopic proximal gastric cancer surgery marked with indocyanine green was lower than that of the control group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Guangyong Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangyong Zhang, Director of General Surgery department, Qianfoshan Hospital

ClinicalTrials.gov Identifier:

NCT05369117

Other Study ID Numbers:

YXLL-KY-2022(021)

First Posted:

May 11, 2022

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Guangyong Zhang, Director of General Surgery department, Qianfoshan Hospital

Indocyanine green

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of May 27, 2022