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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01544413

Enrollment

112

Registered

2012-03-05

Start date

2012-02-29

Completion date

2014-09-30

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Gastric Cancer

Keywords

laparoscopic sentinel lymph node biopsy, quality control study, early gastric cancer

Brief summary

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.

Interventions

PROCEDURELaparoscopic sentinel lymph node biopsy

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Completement of performance of laparoscopic sentinel lymph node biopsy	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

Measure	Time frame	Description
Detection rate of laparoscopic sentinel lymph node, learning curve	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026