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

NCT04219332 | Unknown Phase 3 DMC

• 1 other identifier: FUGES-019
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Indocyanine Green; Gastric Cancer; Injection Site

Outcome Measures

Primary Outcomes (1)

• Total Number of Retrieved Lymph Nodes

  Total Number of Retrieved Lymph Nodes

  One month after surgery

Secondary Outcomes (26)

• Total number of fluorescent lymph nodes in groups A and B

  One month after surgery

• Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)

  One month after surgery

• Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)

  One month after surgery

• Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)

  One month after surgery

• Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)

  One month after surgery

Study Arms (2)

Subserosal injection of indocyanine green tracer group

EXPERIMENTAL

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.

Drug: Subserosa injection of indocyanine green

Submucosal injection of indocyanine green tracer group

ACTIVE COMPARATOR

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

Drug: submucosal injection of indocyanine green

Interventions

Subserosa injection of indocyanine green 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.

Also known as: No other intervention

Subserosal injection of indocyanine green tracer group

submucosal injection of indocyanine green 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.

Also known as: No other intervention

Submucosal injection of indocyanine green tracer 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 from 18 to 75 years
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• 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
• No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
• Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
• American Society of Anesthesiology score (ASA) class I, II, or III
• Written informed consent

You may not qualify if:

• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
• Rejection of laparoscopic resection
• History of allergy to iodine agents
• Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
• History of other malignant disease within past five years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within past six months
• History of cerebrovascular accident within past six months
• History of continuous systematic administration of corticosteroids within one month
• Requirement of simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• Forced expiratory volume in 1 second (FEV1)\<50% of predicted values

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Gastric Surgery

Fuzhou, Fujian, China

Location

Related Publications (10)

• 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.

  PMID: 15908163 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31485904 BACKGROUND

• 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.

  PMID: 27021142 BACKGROUND

• 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.

  PMID: 30756329 BACKGROUND

• 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.

  PMID: 16182120 BACKGROUND

• 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.

  PMID: 21597890 BACKGROUND

• 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.

  PMID: 19106676 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34702260 DERIVED

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 Officials

• Chang-Ming Huang, MD

  Fujian Medical University Union Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Although it was not feasible to blind the surgeons and participants, the pathologists were unaware of the intervention received by the patients. The researcher performing the statistical analyses was blinded to the patient group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 7, 2020
• Study Start: December 31, 2019
• Primary Completion: November 27, 2020
• Study Completion: October 28, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)