Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926743
• Other study ID #: 4-2013-0414
• Status: Completed
• Phase: N/A
• First received: August 18, 2013
• Last updated: November 1, 2017
• Start date: August 1, 2013
• Est. completion date: January 31, 2014

Study information

• Verified date: November 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2014
• Est. primary completion date: January 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Males or Females, aged=20 years and =80 years

2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry

3. American Society of Anesthesiolosists (ASA) score of 1 to 3

4. Histologically confirmed adenocarcinoma in stomach

5. Clinical stage I (T1N0M0, T2N0M0, T1N1M0)

5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study

Exclusion Criteria:

1. M1 status

2. Experience of previous gastric resection

3. Complication due to gastric cancer, such as complete obstruction or perforation

4. History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer

5. History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy
0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Cahill RA, Anderson M, Wang LM, Lindsey I, Cunningham C, Mortensen NJ. Near-infrared (NIR) laparoscopy for intraoperative lymphatic road-mapping and sentinel node identification during definitive surgical resection of early-stage colorectal neoplasia. Surg Endosc. 2012 Jan;26(1):197-204. doi: 10.1007/s00464-011-1854-3. Epub 2011 Aug 19. — View Citation

Jeschke S, Lusuardi L, Myatt A, Hruby S, Pirich C, Janetschek G. Visualisation of the lymph node pathway in real time by laparoscopic radioisotope- and fluorescence-guided sentinel lymph node dissection in prostate cancer staging. Urology. 2012 Nov;80(5):1080-6. doi: 10.1016/j.urology.2012.05.050. Epub 2012 Sep 15. — View Citation

Koyama T, Tsubota A, Nariai K, Mitsunaga M, Yanaga K, Takahashi H. Novel biomedical imaging approach for detection of sentinel nodes in an experimental model of gastric cancer. Br J Surg. 2007 Aug;94(8):996-1001. — View Citation

Marano A, Priora F, Lenti LM, Ravazzoni F, Quarati R, Spinoglio G. Application of fluorescence in robotic general surgery: review of the literature and state of the art. World J Surg. 2013 Dec;37(12):2800-11. doi: 10.1007/s00268-013-2066-x. Review. — View Citation

Nimura H, Narimiya N, Mitsumori N, Yamazaki Y, Yanaga K, Urashima M. Infrared ray electronic endoscopy combined with indocyanine green injection for detection of sentinel nodes of patients with gastric cancer. Br J Surg. 2004 May;91(5):575-9. — View Citation

Ohdaira H, Nimura H, Fujita T, Mitsumori N, Takahashi N, Kashiwagi H, Narimiya N, Yanaga K. Tailoring treatment for early gastric cancer after endoscopic resection using sentinel node navigation with infrared ray electronic endoscopy combined with indocyanine green injection. Dig Surg. 2009;26(4):276-81. doi: 10.1159/000227766. Epub 2009 Jul 8. — View Citation

Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11. — View Citation

Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Löwik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol. 2011 Sep 1;104(3):323-32. doi: 10.1002/jso.21943. Epub 2011 Apr 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging		About 7 days after operation when pathologic result was reported