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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04973475
Other study ID # FUGES-023
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 2021
Est. completion date July 2026

Study information

Verified date July 2021
Source Fujian Medical University
Contact Chang-Ming Huang, MD
Phone +86-13805069676
Email hcmlr2002@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date July 2026
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 (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 4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations 5. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy 6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) 7. American Society of Anesthesiology score (ASA) class I, II, or III 8. 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. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 6. History of other malignant disease within past five years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within past six months 9. History of cerebrovascular accident within past six months 10. History of continuous systematic administration of corticosteroids within one month 11. Requirement of simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. Forced expiratory volume in 1 second (FEV1)<50% of predicted values 14. Rejection of laparoscopic resection 15. Preoperatively confirmed tumors invading the dentate line or duodenum 16. History of allergy to iodine agents 17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

Study Design


Intervention

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

Locations

Country Name City State
China Department of Gastric Surgery Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

References & Publications (14)

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, Mönig S, Kolodziejczyk P, Polkowski W, Pera M, Schneider PM, Wijnhoven B, de Steur WO, Gisbertz SS, Hartgrink H, van Sandick JW, Botticini M, Hölscher 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. — View Citation

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. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Maruyama K, Gunvén 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 True positive rate The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes One month after surgery
Secondary False positive rate The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes One month after surgery
Secondary True negative rate The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes One month after surgery
Secondary Total number of retrieved lymph nodes Total number of retrieved lymph nodes One month after surgery
Secondary Lymph node noncompliance rate Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed. One month after surgery
Secondary Number of Metastasis Lymph Nodes Number of Metastasis Lymph Nodes One month after surgery
Secondary Metastasis rate of lymph node Metastasis rate of lymph node One month after surgery
Secondary Morbidity and mortality rates This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery. One month after surgery
Secondary 3-year overall survival rate 3-year overall survival rate 36 months
Secondary 3-year disease free survival rate 3-year disease free survival rate 36 months
Secondary 3-year recurrence pattern Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. 36 months
Secondary Intraoperative morbidity rates The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. 1 day
Secondary Time to first ambulation Time to first ambulation in hours is used to assess the postoperative recovery course. 30 days
Secondary Time to first flatus Time to first flatus in days is used to assess the postoperative recovery course. 30 days
Secondary Time to first liquid diet Time to first liquid diet in days is used to assess the postoperative recovery course. 30 days
Secondary Time to first soft diet Time to first soft diet in days is used to assess the postoperative recovery course. 30 days
Secondary Duration of postoperative hospital stay Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. 30 days
Secondary The variation of white blood cell count The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The variation of hemoglobin The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The variation of C-reactive protein The variation of C-reactive protein Preoperative 3 days and postoperative 1, 3, and 5 days
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