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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-03-31

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.

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LATG group

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Group Type EXPERIMENTAL

LATG

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopy-assisted total gastrectomy (LATG)

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No