Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

NCT04973475 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FUGES-023
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.

Conditions

Early Gastric Cancer; Indocyanine Green; Lymph Node Dissection

Keywords

Stomach Neoplasms; Indocyanine Green Tracer; Laparoscopic Distal Gastrectomy; Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

• False negative rate

  The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes

  One month after surgery

Secondary Outcomes (20)

• True positive rate

  One month after surgery

• False positive rate

  One month after surgery

• True negative rate

  One month after surgery

• Total number of retrieved lymph nodes

  One month after surgery

• Lymph node noncompliance rate

  One month after surgery

Study Arms (1)

Experimental: Indocyanine Green Tracer

EXPERIMENTAL

Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer

Also known as: ICG

Experimental: Indocyanine Green Tracer

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 (cT1), 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
• Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
• 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
• 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
• Rejection of laparoscopic resection
• Preoperatively confirmed tumors invading the dentate line or duodenum

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Gastric Surgery

Fuzhou, Fujian, China

Location

Related Publications (14)

• Fock KM. Review article: the epidemiology and prevention of gastric cancer. Aliment Pharmacol Ther. 2014 Aug;40(3):250-60. doi: 10.1111/apt.12814. Epub 2014 Jun 10.

  PMID: 24912650 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Msika S, Chastang C, Houry S, Lacaine F, Huguier M. Lymph node involvement as the only prognostic factor in curative resected gastric carcinoma: a multivariate analysis. World J Surg. 1989 Jan-Feb;13(1):118-23; discussion 123. doi: 10.1007/BF01671171.

  PMID: 2471364 BACKGROUND

• Maruyama K, Gunven P, Okabayashi K, Sasako M, Kinoshita T. Lymph node metastases of gastric cancer. General pattern in 1931 patients. Ann Surg. 1989 Nov;210(5):596-602. doi: 10.1097/00000658-198911000-00005.

  PMID: 2818028 BACKGROUND

• Zhang YX, Yang K. Significance of nodal dissection and nodal positivity in gastric cancer. Transl Gastroenterol Hepatol. 2020 Apr 5;5:17. doi: 10.21037/tgh.2019.09.13. eCollection 2020.

  PMID: 32258521 BACKGROUND

• Mocellin S. The Effect of Lymph Node Dissection on the Survival of Patients With Operable Gastric Carcinoma. JAMA Oncol. 2016 Oct 1;2(10):1363-1364. doi: 10.1001/jamaoncol.2016.2044.

  PMID: 27442439 BACKGROUND

• Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.

  PMID: 32060757 BACKGROUND

• Sasako M, McCulloch P, Kinoshita T, Maruyama K. New method to evaluate the therapeutic value of lymph node dissection for gastric cancer. Br J Surg. 1995 Mar;82(3):346-51. doi: 10.1002/bjs.1800820321.

  PMID: 7796005 BACKGROUND

• Kurokawa Y, Takeuchi H, Doki Y, Mine S, Terashima M, Yasuda T, Yoshida K, Daiko H, Sakuramoto S, Yoshikawa T, Kunisaki C, Seto Y, Tamura S, Shimokawa T, Sano T, Kitagawa Y. Mapping of Lymph Node Metastasis From Esophagogastric Junction Tumors: A Prospective Nationwide Multicenter Study. Ann Surg. 2021 Jul 1;274(1):120-127. doi: 10.1097/SLA.0000000000003499.

  PMID: 31404008 BACKGROUND

• Baiocchi GL, Giacopuzzi S, Reim D, Piessen G, Costa PMD, Reynolds JV, Meyer HJ, Morgagni P, Gockel I, Santos LL, Jensen LS, Murphy T, D'Ugo D, Rosati R, Fumagalli Romario U, Degiuli M, Kielan W, Monig S, Kolodziejczyk P, Polkowski W, Pera M, Schneider PM, Wijnhoven B, de Steur WO, Gisbertz SS, Hartgrink H, van Sandick JW, Botticini M, Holscher AH, Allum W, De Manzoni G. Incidence and Grading of Complications After Gastrectomy for Cancer Using the GASTRODATA Registry: A European Retrospective Observational Study. Ann Surg. 2020 Nov;272(5):807-813. doi: 10.1097/SLA.0000000000004341.

  PMID: 32925254 BACKGROUND

• Han SU, Hur H, Lee HJ, Cho GS, Kim MC, Park YK, Kim W, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC). Ann Surg. 2021 Feb 1;273(2):315-324. doi: 10.1097/SLA.0000000000003883.

  PMID: 33064386 BACKGROUND

• Liu M, Xing J, Xu K, Yuan P, Cui M, Zhang C, Yang H, Yao Z, Zhang N, Tan F, Su X. Application of Near-Infrared Fluorescence Imaging with Indocyanine Green in Totally Laparoscopic Distal Gastrectomy. J Gastric Cancer. 2020 Sep;20(3):290-299. doi: 10.5230/jgc.2020.20.e25. Epub 2020 Aug 31.

  PMID: 33024585 BACKGROUND

• Roh CK, Choi S, Seo WJ, Cho M, Son T, Kim HI, Hyung WJ. Indocyanine green fluorescence lymphography during gastrectomy after initial endoscopic submucosal dissection for early gastric cancer. Br J Surg. 2020 May;107(6):712-719. doi: 10.1002/bjs.11438. Epub 2020 Feb 7.

  PMID: 32031248 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

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chang-Ming Huang, MD

  Fujian Medical University Union Hospital

  STUDY CHAIR

Central Study Contacts

Chang-Ming Huang, MD

CONTACT

+86-13805069676; hcmlr2002@163.com

Zu-Kai Wang, MD

CONTACT

+86-15659036263; 413966027@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

CN (1)