NCT01926743

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2014

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

August 18, 2013

Last Update Submit

November 1, 2017

Conditions

Gastric Cancer

Keywords

near infraredfluorescence imagingindocyanine greengastrectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

NIR with ICG group

EXPERIMENTAL
Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy

Interventions

Near infrared fluorescence imaging during laparoscopic or robotic gastrectomyPROCEDURE

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

NIR with ICG group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or Females, aged≥20 years and ≤80 years
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
  • American Society of Anesthesiolosists (ASA) score of 1 to 3
  • Histologically confirmed adenocarcinoma in stomach
  • Clinical stage I (T1N0M0, T2N0M0, T1N1M0)
  • \. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study

You may not qualify if:

  • M1 status
  • Experience of previous gastric resection
  • Complication due to gastric cancer, such as complete obstruction or perforation
  • History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer
  • History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (8)

  • 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.

    PMID: 23645129BACKGROUND

  • 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.

    PMID: 21495033BACKGROUND

  • 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.

    PMID: 21996262BACKGROUND

  • 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.

    PMID: 19590206BACKGROUND

  • 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.

    PMID: 15122608BACKGROUND

  • 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.

    PMID: 17380563BACKGROUND

  • 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.

    PMID: 22990053BACKGROUND

  • 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.

    PMID: 21853392BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2013

First Posted

August 21, 2013

Study Start

August 1, 2013

Primary Completion

January 31, 2014

Study Completion

January 31, 2014

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

KR(1)