Clinical Trial for Laparoscopic D2 Gastrectomy (NCC181)

July 16, 2010 updated by: National Cancer Center, Korea

A Phase-II Clinical Trial of Laparoscopy-Assisted Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer

Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective surgical option.

Methods: total 64 patients, who are diagnosed preoperatively as having T1-2, N0-1 or M0 gastric cancer, will be prospectively enrolled to undergo LADG with D2 lymph node dissection; two surgeons with experience of over 50 cases of laparoscopic gastrectomy performed the procedures. The compliance rate, defined as cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping, for the open gastrectomy with D2 lymph node dissection was 66.0% in a pilot study and was used for calculations of sample size. Compliance rate and other surgical outcomes, including the number of retrieved lymph nodes from each lymph node station, morbidities, mortalities and conversion rate will be analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is the most common cancer in Korea; the overall age-standardized incidence rates of gastric cancer in Korea have been reported to be 69.6 per 100,000 among males and 26.8 per 100,000 among females in 2000.

Treatment modalities for resectable gastric cancer include endoscopic mucosal resection (EMR), laparoscopy-assisted gastrectomy (LAG) and conventional open gastrectomy. Laparoscopic cancer surgery has been reported to be an acceptable alternative to open surgery in patients with colorectal cancer. However, in gastric cancer, laparoscopic surgery has not yet been validated and, thus, is performed only in a limited number of patients with early gastric cancer; this is due to the technical difficulty in systematic lymph node dissection. For the treatment of advanced gastric cancer (AGC), in countries including Korea and Japan, gastrectomy with D2 lymph node dissection has been the standard operation. With the recent progress in diagnostic techniques, accumulation of experience with laparoscopy-assisted distal gastrectomy (LADG) for early gastric cancer and the increasing interest in a better quality of life, there has been an effort to apply minimally invasive techniques to the treatment of AGC. However, there has been no clinical trial to test the oncological feasibility of LADG with D2 lymph node dissection. There is only one phase-II study that evaluated whether the morbidity associated with LADG was higher than that of open gastrectomy.

Before the indications for LADG can be extended to include patients with advanced cancer, the status of surgical expertise for complete D2 lymph node dissection requires investigation using a prospective clinical study design. If this approach is shown to be feasible, a randomized prospective clinical trial, to compare survival and other surgical outcomes, would be the next step in validating this technique for this group of patients.

This study is to be performed according to the Helsinki Declaration. The study was approved by the Ethics Subcommittee at the National Cancer Center for Research Involving Human Subjects (no. NCCCTS-2005181). All patients will be provided written informed consent before entering the study.

Sample size The sample size was based on the alpha error at 0.05 and 90% of power and the accepted margin of the difference in the compliance rate at 10% based on a non-inferiority test. The target was chosen from the primary end point of the study. For the patients who underwent LADG with D2 lymph node dissection, the compliance rate-defined as cases in which there was no more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping,11,12-was set up to 55%; for the patients with open distal gastrectomy with D2 lymph node dissection, it was 66%, based on a pilot study. We performed a pilot study to determine the compliance rate in 100 cases of open distal gastrectomy with D2 lymph node dissection before enrollment started. When the data was used for the formula, the total sample size required was determined to be 60 patients. When we added 10% for expected follow-up loss, the total sample size was calculated to be 66 patients.

Study Type

Interventional

Enrollment (Actual)

64

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
    • Gyeonggido
      • Goyang, Gyeonggido, Korea, Republic of, 411-769
        • National Cancer Center

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the stomach,
  • Age between 18 and 75 years, performance status of ECOG 0-1
  • Signed informed consent
  • Location of the primary tumor in the antrum, angle and lower body
  • No evidence of distant metastasis or invasion to adjacent organs or serosal infiltration,
  • Enlarged lymph node size 2 cm or less on CT and no conglomerate nodes or regional
  • Lymph node metastasis confined to perigastric nodes (N1) as shown on by CT and EUS

Exclusion Criteria:

  • Metastatic disease, previous history of malignancy in any organ, any co-morbidity
  • Obviating major surgery, contraindication to laparoscopy such as severe cardiac disease
  • Abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy, previous upper abdominal surgery, complicated cases requiring emergency surgery, and an accompanying surgical condition requiring surgery at the same time

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: Laparoscopic D2 gastrectomy
Procedure: Laparoscopic D2 distal gastrectomy
Under general endotracheal anesthesia, Five or six ports are used. Lymph node dissection and ligation of vessels are carried out in the laparoscopic field. A partial omentectomy encompassing perigastric nodes is performed laparoscopically. D2 lymphadenectomy is carried out according to the guidelines of the "The Japanese Research Society for Gastric Cancer" for the corresponding location of the primary tumor. A 5- to 6-cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, the stomach is removed from the abdominal cavity and resected. A Billroth-I gastroduodenostomy using an EEA stapler and GIA or a Billroth-II gastrojejunostomy with a hand-sewing technique is performed. The abdomen is then closed after hemostasis is achieved.
Other Names:
  • LADG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance of lymph node dissection
Time Frame: immediate postoperative 1 week
noncompliance : if two or more nodal station is vacant, it is a noncompliant D2 gastrectomy.
immediate postoperative 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with retrieved lymph nodes less than 26
Time Frame: Postoperative 1 week
Postoperative 1 week
operative complications
Time Frame: Postoperative 1 month
intra, and postopertive complications related to operation.
Postoperative 1 month
operative time
Time Frame: postoperative 1 day
postoperative 1 day
estimated blood loss
Time Frame: postoperative 1 day
blood loss during operation.
postoperative 1 day
amount of administered analgesics
Time Frame: Postoperative 1 week
Postoperative 1 week
time to diet
Time Frame: postoperative 1 week
postoperative 1 week
time to return of bowel movement
Time Frame: postoperative 1 week
postoperative 1 week
hospital stay
Time Frame: postoperative 1 week
postoperative 1 week
distance to resection margin and number of harvested lymph nodes
Time Frame: postoperative 1 week
postoperative 1 week

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Young-Woo Kim, MD, PhD, NCC Korea

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

April 1, 2006

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

July 19, 2010

Last Update Submitted That Met QC Criteria

July 16, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-2005181

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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