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

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy

• Registration Number: NCT01926743
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08-01
• Study First Submitted: 2013-08-18
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-21
• Primary Completion: 2014-01-31
• Study Completion: 2014-01-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIR with ICG group	Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of