Evaluation of the Efficacy and Safety of Indocyanine Green Tracing in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer

NCT06421220 | Not Yet Recruiting

• 1 other identifier: KYLL-202403-012-1
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study To evaluate whether the clinical efficacy of submucosal injection of indocyanine green tracer laparoscopic gastric cancer lymph node dissection is superior to that of laparoscopic gastric cancer lymph node dissection without indocyanine green tracer in 3D fluorescence laparoscopic mode in patients with gastric adenocarcinoma (cT1-4a, N-/+, M0). To observe the role of submucosal injection of ICG for tumor localization in fluorescence 3D fluorescence laparoscopic surgery and the application of lymph node dissection in laparoscopic radical surgery for gastric cancer. Study design. Multicenter, randomized, open, parallel-controlled, superiority design. Subgroups Group A (experimental group): indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group Group B (control group): no indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group. Study population Patients who met all the inclusion criteria and did not fall into any of the exclusion criteria were eligible to enter this study. Randomization Patients were first evaluated preoperatively to determine that they could receive laparoscopic radical gastric cancer treatment and receive endoscopic indocyanine green labeling. Once the enrolled cases were determined to meet the admission criteria after laparoscopic exploration, they could be enrolled in this study for randomization. The central dynamic, stratified zone randomization method was used in this study, and the control factors considered were age, tumor site, and preoperative stage. Given the number of seeds and the length of the zones, SAS 9.2 programming was applied to generate the treatment allocation corresponding to the running number 484, which was deposited in the data center. A person at the participating research center was responsible for sending the enrolled case information (age, tumor site, and preoperative stage) to the randomization implementation department at the data center by email, phone, or SMS, and the contact person at each respective research center confirmed that the patient met the enrollment criteria, contacted the contact person for the assigned case in this study, and determined the enrollment of the case by further analyzing the case information, and at the same time, notified the contact person at the research center where the case was located The contact person of the research center where the case is located will be notified at the same time. Competitive enrollment was used in this study. Blinding.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 2-year disease free survival rate

  Observation of the rate of disease-free survival of patients two years after surgery

  12 weeks

Study Arms (2)

Indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group

EXPERIMENTAL

Procedure: Preoperative injection of indocyanine green

Indocyanine green tracer-free 3D laparoscopic gastric cancer lymph node dissection group

NO INTERVENTION

Interventions

Preoperative injection of indocyanine green PROCEDURE

Submucosal injection of indocyanine green into the gastric mucosa prior to surgery， indocyanine green，25mg，powder，once

Indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion (pap, tub, muc, sig, por) The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage.
• Preoperative examination did not show distant metastasis, and the tumor did not directly invade the pancreas, spleen and other adjacent organs.
• Preoperative ECOG physical status score 0/1 Preoperative ASA score I-III. Patient informed consent

You may not qualify if:

• Pregnant or nursing women Serious mental illness History of upper abdominal surgery (except history of laparoscopic cholecystectomy) History of gastric surgery (including ESD/EMR for gastric cancer) Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm) History of other malignant diseases within 5 years. Neoadjuvant therapy has been implemented History of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months History of continuous systemic corticosteroid therapy within 1 month Require concomitant surgical treatment for other diseases. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery.
• Pulmonary function test FEV1 \<50% of the expected value Diffusely invasive gastric cancer Preoperatively confirmed tumor invading the dentate line or duodenum Previous history of iodine allergy Refusal of laparoscopic surgery

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (7)

• Wei M, Liang Y, Wang L, Li Z, Chen Y, Yan Z, Sun D, Huang Y, Zhong X, Liu P, Yu W. Clinical Application of Indocyanine Green Fluorescence Technology in Laparoscopic Radical Gastrectomy. Front Oncol. 2022 Mar 4;12:847341. doi: 10.3389/fonc.2022.847341. eCollection 2022.

  PMID: 35311067 RESULT

• Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267.

  PMID: 30427990 RESULT

• Kim TH, Kong SH, Park JH, Son YG, Huh YJ, Suh YS, Lee HJ, Yang HK. Assessment of the Completeness of Lymph Node Dissection Using Near-infrared Imaging with Indocyanine Green in Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2018 Jun;18(2):161-171. doi: 10.5230/jgc.2018.18.e19. Epub 2018 Jun 28.

  PMID: 29984066 RESULT

• Lan YT, Huang KH, Chen PH, Liu CA, Lo SS, Wu CW, Shyr YM, Fang WL. A pilot study of lymph node mapping with indocyanine green in robotic gastrectomy for gastric cancer. SAGE Open Med. 2017 Aug 21;5:2050312117727444. doi: 10.1177/2050312117727444. eCollection 2017.

  PMID: 28856007 RESULT

• Huh YJ, Lee HJ, Kim TH, Choi YS, Park JH, Son YG, Suh YS, Kong SH, Yang HK. Efficacy of Assessing Intraoperative Bowel Perfusion with Near-Infrared Camera in Laparoscopic Gastric Cancer Surgery. J Laparoendosc Adv Surg Tech A. 2019 Apr;29(4):476-483. doi: 10.1089/lap.2018.0263. Epub 2018 Dec 27.

  PMID: 30589374 RESULT

• Sherwinter DA, Boni L, Bouvet M, Ferri L, Hyung WJ, Ishizawa T, Kaleya RN, Kelly K, Kokudo N, Lanzarini E, Luyer MDP, Mitsumori N, Mueller C, Park DJ, Ribero D, Rosati R, Ruurda JP, Sosef M, Schneider-Koraith S, Spinoglio G, Strong V, Takahashi N, Takeuchi H, Wijnhoven BPL, Yang HK, Dip F, Lo Menzo E, White KP, Rosenthal RJ. Use of fluorescence imaging and indocyanine green for sentinel node mapping during gastric cancer surgery: Results of an intercontinental Delphi survey. Surgery. 2022 Dec;172(6S):S29-S37. doi: 10.1016/j.surg.2022.06.036.

  PMID: 36427927 RESULT

• Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033.

  PMID: 32101269 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor， and Chief of Gastrointestinal Surgery Department

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 20, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)