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Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC


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

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Trial Information

Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC


Inclusion Criteria:



- Patients must have documented diagnosis of gastric cancer

- Patients receiving laparoscopic gastric cancer surgery without preoperative evidence
of serosal invasion and distant lymph node metastasis as determined by evaluation of
preoperative CT-scan, upper endoscopy, or endoscopic ultrasound.

- Patients undergoing gastric cancer surgery without plans for combined operations,
such as resection of another organ for another primary disease.

- Patients who have received comprehensive explanation about the planned study,
understand and accept all the terms of the study and willingly give consent to
participate in all the required elements of the study

Exclusion Criteria:

- Patients without mental competence

- Patients who are illiterate

- Patients who are pregnant

- Patients < 20 and > 80 years old

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Evaluation of operative procedure according to predetermined criteria

Outcome Description:

Video recording during the operation Peer reviewer's evaluation according to predetermined criteria Final approval by review committee Predetermined criteria: exact dissection of lymph node (LN) station satisfying each requirements (omentum, LN1, LN3, LN4sb, LN4d, LN5, LN6, LN7, LN8a, LN9, LN11p and LN12a)

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

4-2010-0637

NCT ID:

NCT01283893

Start Date:

December 2010

Completion Date:

August 2013

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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