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

Not Applicable

• Conditions: Total Laparoscopic Distal Gastrectomy; Locally Advanced Gastric Cancer
• Interventions: Procedure: TLDG or LADG

• Registration Number: NCT02365896
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-27
• Study Start: 2015-06
• Primary Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
postoperative early anastomotic morbidity	30 days

Secondary Outcome Measures

Name	Time	Method
Pain score	10 days
Quality of life	30 days	estimated with EORTC QLQ-C30V3、EORTC QLQ-STO22
Flatus time	7 days
Postoperative hospital stay	30 days
Postoperative inflammation response	10 days	using C-reactive protein、IL-6、WBC and so on postoperative 1,3,5,7 days
Nutrition	30 days	NRS-2002 and PG-SGA in 30 days