Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hwasun Hospital, Hwasun, Chonnam, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

gastric adenocarcinoma in preoperative endoscopic biopsy
clinical stage T1-2N0
long diameter of tumor <4cm
distance between tumor and pylorus or cardia >2cm
age: 20-80
ECOG: 1 or 0
patients will undergo laparoscopic gastrectomy

Exclusion criteria

definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type, no ulcer)
no indication for surgery for cardiovascular, pulmonary disease
pregancy
drug allergy or previous abdominal surgery, radiotherpy

Treatment and study plan

Laparoscopic sentinel lymph node biopsy

Procedure

During the operation, endoscopic marking was perfomed using Tc 99m HSA and indocyanine green around tumor. Then we identify the sentinel lymph node with laparoscopic probe. Laparoscopic sentinel lymph nodes were dissedted and evaluated them at the backtable in the operating room.

Other names: Tc 99m HSA (Frosstimage), indocyanine green (IC-GREEN™ (Akorn)), laparoscopic probe (neoprobe® GDS gamma detection system)

Primary outcomes

Completement of performance of laparoscopic sentinel lymph node biopsy

Time frame: within 24 hours after operation

Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours.

Secondary outcomes

Detection rate of laparoscopic sentinel lymph node, learning curve

Time frame: upto 2 years

Detection rate of laparoscopic sentinel lymph node is evaluated within 7 days after operation by pathological examination. Learning curve can be drawn after all cases' data are collected, so it takes upto 2 years.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Mar 5, 2012
Registry last updated: Dec 16, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed