Clinical Trial for Laparoscopic D2 Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Laparoscopic D2 distal gastrectomy
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): LADG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: D2 lymph node dissection