Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations

• Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale

• ASA (American Society of Anesthesiology) class I to III

• Written informed consent

Locations
Other Locations
China
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Mi Lin
silihuala@qq.com
13459152658
Backup
Hua-Long Zheng
291167038@qq.com
18359190587
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 702
Treatments
Experimental: 3D-4K-ICG
Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
Experimental: 4K-ICG
Indocyanine Green Tracer Using in Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
Placebo_comparator: 3D
3D Laparoscopic Gastrectomy with Lymph Node Dissection
Related Therapeutic Areas
Sponsors
Leads: Fujian Medical University

This content was sourced from clinicaltrials.gov

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