A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
|ClinicalTrials.gov Identifier: NCT02311595|
Recruitment Status : Unknown
Verified December 2014 by Samsung Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: reduced port laparoscopic distal gastrectomy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
Experimental: reduced port
gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection
Procedure: reduced port laparoscopic distal gastrectomy
- Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping) [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311595
|Contact: Jun Ho Lee, M.D. ph.Demail@example.com|
|Contact: Jieun Kim, M.D.||firstname.lastname@example.org|
|Study Chair:||Jun Ho Lee, M.D. ph.D||Samsung Medical Center|