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

Early Gastric Cancer Clinical Trial

Official title:

Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04973475
• Other study ID #: FUGES-023
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Indocyanine Green
• Lymph Node Dissection
• Stomach Neoplasms

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

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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

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* Note: There are 14 references in all — Click 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