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

February 5, 2014 updated by: Gyu-Seok Cho, Soonchunhyang University Hospital

Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
          • Seung Wan Ryu, M.D., Ph.D.
          • Phone Number: +82-53-250-8322
          • Email: gsman@dsmc.or.kr
        • Principal Investigator:
          • Seung Wan Ryu, M.D., Ph.D
      • Daegu, Korea, Republic of, 702-210
        • Recruiting
        • Kyungpook National University Medical Center
        • Contact:
        • Principal Investigator:
          • Oh Kyoung Kwon, M.D., Ph.D.
      • Incheon, Korea, Republic of, 403-720
        • Recruiting
        • Incheon St, Mary's Hostpial, The Catholic University of Korea
        • Contact:
        • Principal Investigator:
          • Jin Jo Kim, M.D.
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Seong Ho Kong, M.D., Ph.D.
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei University Severance Hospital
        • Contact:
        • Principal Investigator:
          • Hyoung Il Kim, M.D., Ph.D.
      • Seoul, Korea, Republic of, 110-799
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hyuk Joon Lee, M.D., Ph.D.
          • Phone Number: +82-2-2072-1957
          • Email: appe98@snu.ac.kr
        • Principal Investigator:
          • Hyuk Joon Lee, M.D., Ph.D.
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-767
        • Recruiting
        • Soonchunhyang University Bucheon Hospital
        • Principal Investigator:
          • Gyu Seok Cho, M.D., Ph.D.
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gui Ae Jeong, M.D., Ph.D.
      • Suwon, Gyeonggi-do, Korea, Republic of, 443-749
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Sang Uk Han, M.D., Ph.D.
          • Phone Number: +82-31-219-5200
          • Email: hansu@ajou.ac.kr
        • Principal Investigator:
          • Sang Uk Han, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Laparoscopy-assisted total gastrectomy (LATG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Investigators

  • Principal Investigator: Gyu-Seok Cho, M.D., Ph.D., Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

April 22, 2012

First Submitted That Met QC Criteria

April 22, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLASS-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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