Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy With Nodal Dissection for Clinical Stage I Gastric Cancer (KLASS-03)
20 Years
80 Years
Both
Gastric Cancer
Trial Information
Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy With Nodal Dissection for Clinical Stage I Gastric Cancer (KLASS-03)
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The incidence of postoperative morbidity and mortality
Outcome Description:
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, intraabdominal fluid collection or abscess, intraabdominal 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
Outcome Time Frame:
1 month
Safety Issue:
Yes
Principal Investigator
Gyu-Seok Cho, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Soonchunhyang University Bucheon Hospital
Authority:
South Korea: Institutional Review Board
Study ID:
KLASS-03
NCT ID:
NCT01584336
Start Date:
July 2012
Completion Date:
January 2014
Related Keywords:
- Gastric Cancer
- Gastric cancer, laparoscopy-assisted total gastrectomy
- Stomach Neoplasms
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