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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Soonchunhyang University Hospital
Sponsor:
Information provided by (Responsible Party):
Gyu-Seok Cho, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01584336
First received: April 22, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584336

Contacts
Contact: Gyu-Seok Cho, M.D., Ph.D. +82-32-621-5248 gschogs@schmc.ac.kr
Contact: Gui-Ae Jeong, M.D., Ph.D. +82-621-5254 gwsdlove@schmc.ac.kr

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital Recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-767
Contact: Gyu Seok Cho, M.D., Ph.D.    +82-32-621-5814    gschogs@schmc.ac.kr   
Contact: Gui Ae Jeong, M.D., Ph.D.    +82-32-621-5834    gwsdlove@schmc.ac.kr   
Principal Investigator: Gyu Seok Cho, M.D., Ph.D.         
Sub-Investigator: Gui Ae Jeong, M.D., Ph.D.         
Ajou University Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 443-749
Contact: Sang Uk Han, M.D., Ph.D.    +82-31-219-5200    hansu@ajou.ac.kr   
Principal Investigator: Sang Uk Han, M.D., Ph.D.         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Seung Wan Ryu, M.D., Ph.D.    +82-53-250-8322    gsman@dsmc.or.kr   
Principal Investigator: Seung Wan Ryu, M.D., Ph.D         
Kyungpook National University medical Center Recruiting
Daegu, Korea, Republic of, 702-210
Contact: Oh Kyoung Kwon, M.D., Ph.D.    +82-53-200-3062    kok007@hanmail.net   
Principal Investigator: Oh Kyoung Kwon, M.D., Ph.D.         
Incheon St, Mary's Hostpial, The Catholic University of Korea Recruiting
Incheon, Korea, Republic of, 403-720
Contact: Jin Jo Kim, M.D.    +82-1544-9004    kjj@catholic.ac.kr   
Principal Investigator: Jin Jo Kim, M.D.         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woo Jin Hyung, M.D., Ph.D.    +82-2-2227-0114    wjhyung@yumc.yonsei.ac.kr   
Principal Investigator: Woo Jin Hyung, M.D., Ph.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-799
Contact: Hyuk Joon Lee, M.D., Ph.D.    +82-2-2072-1957    appe98@snu.ac.kr   
Principal Investigator: Hyuk Joon Lee, M.D., Ph.D.         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyoung Il Kim, M.D.    +82-2-2227-0114    cairus@naver.com   
Principal Investigator: Hyoung Il Kim, M.D., Ph.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seong Ho Kong, M.D., Ph.D.    +82-2-2072-2114    wisehearted@gmail.com   
Principal Investigator: Seong Ho Kong, M.D., Ph.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-799
Contact: Han Kwang Yang, M.D., Ph.D.    +82-2-2072-3797    hkyang@snu.ac.kr   
Principal Investigator: Han Kwang Yang, M.D., Ph.D.         
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Principal Investigator: Gyu-Seok Cho, M.D., Ph.D. Soonchunhyang University Hospital
  More Information

Publications:

Responsible Party: Gyu-Seok Cho, Soonchunhyang University Bucheon Hospital, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01584336     History of Changes
Other Study ID Numbers: KLASS-03
Study First Received: April 22, 2012
Last Updated: February 5, 2014
Health Authority: South Korea: Institutional Review Board

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 29, 2014