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


N/A
20 Years
80 Years
Open (Enrolling)
Both
Early Gastric Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Completement of performance of laparoscopic sentinel lymph node biopsy

Outcome Description:

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.

Outcome Time Frame:

within 24 hours after operation

Safety Issue:

No

Principal Investigator

Keun Won Ryu, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

SENORITA-2012

NCT ID:

NCT01544413

Start Date:

February 2012

Completion Date:

December 2013

Related Keywords:

  • Early Gastric Cancer
  • laparoscopic sentinel lymph node biopsy
  • quality control study
  • early gastric cancer
  • Stomach Neoplasms

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