Clinical trial · Interventional
Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy
NCT01926743CI-TRIAL-00030162completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NIR with ICG group
- interventionNames
- Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy
Primary outcomes (1)
- measure
- To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging
- timeFrame
- About 7 days after operation when pathologic result was reported
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDMarano 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. PMID 23645129
- BACKGROUNDSchaafsma 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. PMID 21495033
- BACKGROUNDRossi 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. PMID 21996262
- BACKGROUNDOhdaira 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. PMID 19590206
- BACKGROUNDNimura 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. PMID 15122608
- BACKGROUNDKoyama 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. PMID 17380563
- 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.