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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: LATG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LATG group<br>It means the patients who will be enrolled in our study. | Procedure: LATG<br>* 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 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). The operator can choose any reconstruction method of esophagojejunostomy according to surgeon's preference. After then, the operator performs the jejunojejunostomy.<br>* Other names: Laparoscopy-assisted total gastrectomy (LATG);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative morbidity and mortality | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, laparoscopy-assisted total gastrectomy