A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection

Phase 2

• Conditions: Gastric Cancer
• Interventions: Procedure: reduced port laparoscopic distal gastrectomy

• Registration Number: NCT02311595
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.

67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.

The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-05
• Last Update Submitted: 2014-12-05
• Study First Posted: 2014-12-08
• Last Update Posted: 2014-12-08
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• histologically confirmed adenocarcinoma of the stomach
• Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1,
• signed informed consent
• location of the primary tumor in the antrum, angle and lower body
• no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration

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Exclusion Criteria

• metastatic disease
• previous history of malignancy in any organ
• any co-morbidity obviating major surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
reduced port	reduced port laparoscopic distal gastrectomy	gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection

Primary Outcome Measures

Name	Time	Method
Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)	1 month after enrollment of the patients	Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping