Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, laparoscopy-assisted total gastrectomy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LATG
Type: Procedure
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This study will performed via prospective, multicenter design.
Detailed Description
Gastric cancer remains one of the most common neoplasms in Asia and some western countries, although the incidence is decreasing worldwide. Recently,as the rate of detection of early gastric cancer has increased and surgical techniques have been developed, laparoscopic procedures have been introduced and tried for the treatment of early-stage gastric cancer.

Already the prospective, randomized trials for safety and oncologic outcomes of laparoscopy-assisted distal gastrectomy for gastric cancer had been tried, but the large-scaled, prospective study for laparoscopy-assisted total gastrectomy (LATG) is seldom.

One reason for the low popularity is that LATG requires the dissection of lymph nodes at the splenic hilum or along the short gastric arteries and the other reason is that the reconstruction after total gastrectomy is also more complicated. The third reason is that the chance for total gastrectomy is less frequent than distal gastrectomy because of the low incidence of upper gastric cancer.

This KLASS-03 trial is a prospective, multicenter trial for LATG for early upper gastric cancer. The primary purpose of this study is to evaluate the incidence of postoperative morbidity and mortality and the second purpose is to evaluate the surgical outcomes after several methods of reconstruction in laparoscopic total gastrectomy and the postoperative course of LATG patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy

- range of age ; over 20 years to under 80 years

- preoperative stage : cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC)

- The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction

- the gastric cancer which is not included the indication of the endoscopic mucosal dissection

- ECOG (Eastern Cooperative Oncology Group) performance status; 0 and 1

- ASA (American Society of Anesthesiology) score ; 1, 2, 3

- Written informed consent

Exclusion Criteria:

- The patient who shows distant metastasis under preoperative examination

- The patient with medical history for upper abdominal surgery with open method in the past

- The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past(remnant stomach cancer)

- The patient with double cancer synchronous or metachronous within 5 years

- Enlarged lymph nodes of the splenic hilum in the preoperative evaluation

- The patient who has been enrolled other clinical study within 6 months

- Vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy
Locations
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Gyu Seok Cho, M.D., Ph.D. - +82-32-621-5814 - gschogs@schmc.ac.kr
Ajou University Hospital
Suwon, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Sang Uk Han, M.D., Ph.D. - +82-31-219-5200 - hansu@ajou.ac.kr
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Status: Recruiting
Contact: Seung Wan Ryu, M.D., Ph.D. - +82-53-250-8322 - gsman@dsmc.or.kr
Kyungpook National University medical Center
Daegu, Korea, Republic of
Status: Recruiting
Contact: Oh Kyoung Kwon, M.D., Ph.D. - +82-53-200-3062 - kok007@hanmail.net
Incheon St, Mary's Hostpial, The Catholic University of Korea
Incheon, Korea, Republic of
Status: Recruiting
Contact: Jin Jo Kim, M.D. - +82-1544-9004 - kjj@catholic.ac.kr
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Seong Ho Kong, M.D., Ph.D. - +82-2-2072-2114 - wisehearted@gmail.com
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Han Kwang Yang, M.D., Ph.D. - +82-2-2072-3797 - hkyang@snu.ac.kr
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Hyuk Joon Lee, M.D., Ph.D. - +82-2-2072-1957 - appe98@snu.ac.kr
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Woo Jin Hyung, M.D., Ph.D. - +82-2-2227-0114 - wjhyung@yumc.yonsei.ac.kr
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Hyoung Il Kim, M.D. - +82-2-2227-0114 - cairus@naver.com
Start Date
October 2012
Completion Date
March 2014
Sponsors
Soonchunhyang University Hospital
Source
Soonchunhyang University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page