Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection

NCT ID: NCT04219332

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2023-10-28

Brief Summary

The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphadenectomy for patients with gastric cancer was different. The patients with gastric adenocarcinoma (cT1-4a, N0/+, M0) were studied.

Detailed Description

In recent years, with the successful application of ICG (indocyanine green) fluorescence imaging technology in laparoscopic equipment, scholars have found that ICG near-infrared imaging has better tissue penetration and can better identify lymph nodes in hypertrophic adipose tissue than other dyes under visible light, which makes ICG fluorescence imaging guide laparoscopic radical resection of gastric cancer lymph node dissection has become a new exploration direction. ICG near-infrared imaging technology has important research value, good application prospects, and broad development space in laparoscopic radical resection of gastric cancer. However, at present, the application of ICG near-infrared imaging technology in laparoscopic radical resection of gastric cancer is still in the exploratory stage, and there is no unified standard. Therefore, in the world, there is still a lack of high-level evidence-based evidence of large-sample prospective randomized controlled trials to evaluate the effectiveness, safety, and feasibility of submucosal or subserous injection of ICG in guiding laparoscopic D2 resection of gastric cancer. The investigator first carried out this study in the world to evaluate the lymph node dissection and perioperative safety of gastric cancer patients who received a submucosal injection of ICG and subserous injection of ICG during laparoscopic radical gastrectomy in the same period, to promote the standardized development of ICG near-infrared imaging in laparoscopic radical gastrectomy.

Conditions

Indocyanine Green; Gastric Cancer; Injection Site

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Subserosal injection of indocyanine green tracer group

Subserosal injection of indocyanine green, with a concentration of 0.5 mg /ml, 6 points along the lesser and greater curvature of the stomach, 1.5 ml for each point.

Group Type: EXPERIMENTAL

Subserosa injection of indocyanine green

Intervention Type: DRUG

After preoperative exploration, the indocyanine green powder (Dandong Yichuang Pharmaceutical Co) is dissolved in 0.5 mg/ml of sterile water and the prepared solution (1.5 ml for each point) is injected along the subserosal of the stomach at 6 specific points along the lesser and greater curvature of the stomach.

Submucosal injection of indocyanine green tracer group

Submucosal injection of indocyanine green, with a concentration of 1.25mg /ml, four points around the primary tumor, each point 0.5 ml.

Group Type: ACTIVE_COMPARATOR

submucosal injection of indocyanine green

Intervention Type: DRUG

One day before surgery, 1.25 mg/ml indocyanine green (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water and 0.5 ml of the solution was injected into the submucosal layer at 4 quadrants around the primary tumor, amounting to 2.5 mg of indocyanine green.

Interventions

Subserosa injection of indocyanine green

After preoperative exploration, the indocyanine green powder (Dandong Yichuang Pharmaceutical Co) is dissolved in 0.5 mg/ml of sterile water and the prepared solution (1.5 ml for each point) is injected along the subserosal of the stomach at 6 specific points along the lesser and greater curvature of the stomach.

Intervention Type: DRUG

submucosal injection of indocyanine green

One day before surgery, 1.25 mg/ml indocyanine green (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water and 0.5 ml of the solution was injected into the submucosal layer at 4 quadrants around the primary tumor, amounting to 2.5 mg of indocyanine green.

Intervention Type: DRUG

Other Intervention Names

No other intervention; No other intervention

Eligibility Criteria

Inclusion Criteria

1. Age from 18 to 75 years

2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

3. Clinical stage tumor T1-4a (cT1-4a), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound

4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations

5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)

6. American Society of Anesthesiology score (ASA) class I, II, or III

7. Written informed consent

Exclusion Criteria

1. Women during pregnancy or breast-feeding

2. Severe mental disorder

3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection

5. Rejection of laparoscopic resection

6. History of allergy to iodine agents

7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

8. History of other malignant disease within past five years

9. History of previous neoadjuvant chemotherapy or radiotherapy

10. History of unstable angina or myocardial infarction within past six months

11. History of cerebrovascular accident within past six months

12. History of continuous systematic administration of corticosteroids within one month

13. Requirement of simultaneous surgery for other disease

14. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

15. Forced expiratory volume in 1 second (FEV1)<50% of predicted values

16. Linitis plastica, Widespread

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Ming Huang, Prof.

Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang-Ming Huang, MD

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Locations

Department of Gastric Surgery

Fuzhou, Fujian, China

Countries

China

References

Lee JH, Ryu KW, Kim CG, Kim SK, Choi IJ, Kim YW, Chang HJ, Bae JM, Hong EK. Comparative study of the subserosal versus submucosal dye injection method for sentinel node biopsy in gastric cancer. Eur J Surg Oncol. 2005 Nov;31(9):965-8. doi: 10.1016/j.ejso.2005.03.006.

Reference Type: BACKGROUND

PMID: 15908163 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30427990 (View on PubMed)

Cianchi F, Indennitate G, Paoli B, Ortolani M, Lami G, Manetti N, Tarantino O, Messeri S, Foppa C, Badii B, Novelli L, Skalamera I, Nelli T, Coratti F, Perigli G, Staderini F. The Clinical Value of Fluorescent Lymphography with Indocyanine Green During Robotic Surgery for Gastric Cancer: a Matched Cohort Study. J Gastrointest Surg. 2020 Oct;24(10):2197-2203. doi: 10.1007/s11605-019-04382-y. Epub 2019 Sep 4.

Reference Type: BACKGROUND

PMID: 31485904 (View on PubMed)

Herrera-Almario G, Patane M, Sarkaria I, Strong VE. Initial report of near-infrared fluorescence imaging as an intraoperative adjunct for lymph node harvesting during robot-assisted laparoscopic gastrectomy. J Surg Oncol. 2016 Jun;113(7):768-70. doi: 10.1002/jso.24226. Epub 2016 Mar 29.

Reference Type: BACKGROUND

PMID: 27021142 (View on PubMed)

Chen QY, Zhong Q, Liu ZY, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Li P, Zheng CH, Huang CM. Does Noncompliance in Lymph Node Dissection Affect Oncological Efficacy in Gastric Cancer Patients Undergoing Radical Gastrectomy? Ann Surg Oncol. 2019 Jun;26(6):1759-1771. doi: 10.1245/s10434-019-07217-x. Epub 2019 Feb 12.

Reference Type: BACKGROUND

PMID: 30756329 (View on PubMed)

Bredart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S, Chie WC, Hammerlid E, Arraras JI, Efficace F, Rodary C, Schraub S, Costantini M, Costantini A, Joly F, Sezer O, Razavi D, Mehlitz M, Bielska-Lasota M, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group and Quality of Life Unit. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005 Sep;41(14):2120-31. doi: 10.1016/j.ejca.2005.04.041.

Reference Type: BACKGROUND

PMID: 16182120 (View on PubMed)

Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4.

Reference Type: BACKGROUND

PMID: 21597890 (View on PubMed)

Tajima Y, Yamazaki K, Masuda Y, Kato M, Yasuda D, Aoki T, Kato T, Murakami M, Miwa M, Kusano M. Sentinel node mapping guided by indocyanine green fluorescence imaging in gastric cancer. Ann Surg. 2009 Jan;249(1):58-62. doi: 10.1097/SLA.0b013e3181927267.

Reference Type: BACKGROUND

PMID: 19106676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32101269 (View on PubMed)

Chen QY, Zhong Q, Li P, Xie JW, Liu ZY, Huang XB, Lin GT, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Zheng QL, Tu RH, Huang ZN, Zheng CH, Huang CM. Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial. BMC Med. 2021 Oct 27;19(1):276. doi: 10.1186/s12916-021-02125-y.

Reference Type: DERIVED

PMID: 34702260 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

FUGES-019

Identifier Type: -

Identifier Source: org_study_id