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Multicenter Study on Comparison of Long-term Outcome Between Laparoscopic and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer


Phase 3
19 Years
74 Years
Open (Enrolling)
Both
Stomach Neoplasms

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Trial Information

Multicenter Study on Comparison of Long-term Outcome Between Laparoscopic and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer


Inclusion Criteria:



- Age from over 18 to under 75 years

- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy

- cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging
Manual Seventh Edition

- Expected curative resection through distal subtotal gastrectomy with D2
lymphadenectomy

- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale

- ASA (American Society of Anesthesiology) score class I, II, or III

- Written informed consent

Exclusion Criteria:

- Women during pregnancy or breast-feeding

- Severe mental disorder

- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

- History of previous gastrectomy, endoscopic mucosal resection or endoscopic
submucosal dissection

- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

- History of other malignant disease within past five years

- History of previous neoadjuvant chemotherapy or radiotherapy

- History of unstable angina or myocardial infarction within past six months

- History of cerebrovascular accident within past six months

- History of continuous systematic administration of corticosteroids within one month

- Requirement of simultaneous surgery for other disease

- Emergency surgery due to complication (bleeding, obstruction or perforation) caused
by gastric cancer

- FEV1<50% of predicted values

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year disease free survival rate

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Guoxin Li, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Laparoscopic Gastrointestinal Surgical Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China

Authority:

China: Ministry of Health

Study ID:

CLASS - 01

NCT ID:

NCT01609309

Start Date:

September 2012

Completion Date:

June 2018

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • Laparoscopy
  • Neoplasms
  • Stomach Neoplasms

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