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Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03) (KLASS-03)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Soonchunhyang University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Gyu-Seok Cho, Soonchunhyang University Hospital Identifier:
First received: April 22, 2012
Last updated: February 5, 2014
Last verified: February 2014
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.

Condition Intervention Phase
Gastric Cancer
Procedure: LATG
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)

Resource links provided by NLM:

Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • The incidence of postoperative morbidity and mortality [ Time Frame: 1 month ]

    The primary purpose of this study is that the incidence of morbidity and mortality after LATG. We will access the postoperative morbidity including as follows: wound complication, intra-abdominal fluid collection or abscess, intra-abdominal bleeding, intraluminal bleeding, intestinal obstruction, ileus, anastomotic stenosis, anastomotic leakage, fistula, pancreatitis, pulmonary complication, urinary complication, renal complication, hepatic complication, cardiac complication, endocrine complication, and stasis.

    Also we will evaluate the incidence of postoperative mortality after LATG.

Secondary Outcome Measures:
  • the surgical outcomes according to the method of reconstruction [ Time Frame: 1 month ]
    We will evaluate the difference of surgical outcomes (duration of anastomosis, failure rate of anastomosis, etc) and postoperative morbidity (anastomotic leakage, stenosis, bleeding, etc) according to the methods of reconstruction after gastrectomy. The methods of reconstruction after gastrectomy will be depend to the each operator's decision.

Estimated Enrollment: 168
Study Start Date: October 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LATG group
It means the patients who will be enrolled in our study.
Procedure: LATG
  1. After laparoscopic observation, the surgeon must check the possibility of laparoscopic surgery (without the serosal invasion of cancer or peritoneal metastasis or lymph node metastasis to splenic hilum). If the gastric cancer with serosal invasion or grossly lymph node metastasis to splenic hilum, operator must convert the operation method to open gastrectomy
  2. The operator undergoes the laparoscopic total gastrectomy with lymph node dissection(including the status of lymph nodes - No #1,2,3,4sa,4sb,4d,5,6,7,8a,9,11p and 11d, and/or 12a).
  3. The operator can choose any reconstruction method of esophagojejunostomy according to surgeon's preference.
  4. After then, the operator performs the jejunojejunostomy.
Other Name: Laparoscopy-assisted total gastrectomy (LATG)

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.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01584336

Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-767
Ajou University Hospital
Suwon, Gyeonggi-do, Korea, Republic of, 443-749
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Kyungpook National University medical Center
Daegu, Korea, Republic of, 702-210
Incheon St, Mary's Hostpial, The Catholic University of Korea
Incheon, Korea, Republic of, 403-720
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Soonchunhyang University Hospital
Principal Investigator: Gyu-Seok Cho, M.D., Ph.D. Soonchunhyang University Hospital
  More Information


Responsible Party: Gyu-Seok Cho, Soonchunhyang University Bucheon Hospital, Soonchunhyang University Hospital Identifier: NCT01584336     History of Changes
Other Study ID Numbers: KLASS-03 
Study First Received: April 22, 2012
Last Updated: February 5, 2014

Keywords provided by Soonchunhyang University Hospital:
Gastric cancer, laparoscopy-assisted total gastrectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases processed this record on February 17, 2017