Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Fujian Provincial Cancer Hospital

Status: Unknown

Conditions: Locally Advanced Gastric Cancer; Total Laparoscopic Distal Gastrectomy

Treatments: Procedure: TLDG or LADG

Study type: Interventional

Funder types: Other

Identifiers

NCT02365896

TLDG vs. LADG

Details and patient eligibility

About

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The diagnosis of gastric cancer was confirmed by pathological examination
• Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th
• No accompany with another cancer
• ECOG 0-1
• ASA I-III
• Agreement

Exclusion criteria

• Pregnant or suckling period
• Patients with a history of preoperative chemoradiotherapy
• Patients with unable to finish D2 lymphadenectomy or R0 resection
• Laparoscopic surgery contraindications
• Serious organ disfunction
• Accompany with serious mental disease
• Continuous treatment with steroid in 1 month
• Disagreement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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176 participants in 1 patient group

TLDG or LADG

Other group

Description:

To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG

Treatment:

Procedure: TLDG or LADG