Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy
NCT ID: NCT01926743
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-08-01
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NIR with ICG group
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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References
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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.
Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Lowik 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.
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.
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.
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. doi: 10.1002/bjs.4470.
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. doi: 10.1002/bjs.5650.
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.
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.
Other Identifiers
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4-2013-0414
Identifier Type: -
Identifier Source: org_study_id