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Completed

NCT Number: NCT01441310

Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.

The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

About this study

Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.

Laparoscopic SNNS:

  • ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
  • Sentinel node basin identification and dissection
  • Sentinel nodes picking in back table
  • Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
  • If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.

Sample size: 100 cases

Study duration: 5 years( 2year enrollment, 3 year follow-up)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-80
  • Informed consent
  • No other malignancies
  • cT1N0 stage gastric cancers < 4cm
  • no allergic history of isotope

Exclusion criteria

  • Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication

Treatment and study plan

Laparoscopic sentinel node navigation surgery

Procedure

Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections

Primary outcomes

  1. 3 Year disease free survival

    Time frame: Postoperative 3 year

    Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.

Secondary outcomes

  1. Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.

    Time frame: postoperative 1, 3, 6, 12 month

    Sentinel node detection rate and occurrence of complication of SNNS using dual method for gastric cancer were evaluated QoL questennaire and remnant stomach function were evaluated for the evaluation of patient's quality of life

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Acronym: SNNS

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
Sep 27, 2011
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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