Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: Procedure: open distal gastrectomy; Procedure: laparoscopy assisted distal gastrectomy

• Registration Number: NCT01088204
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.

Detailed Description

To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

Study Timeline

• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Study Start: 2010-06
• Primary Completion: 2011-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• histologically proven primary gastric adenocarcinoma

• T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location

• No evidence of other distant metastasis

• not stump carcinoma,(vi) aged 20-80 year old

• performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale

• no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection

• adequate organ functions defined as indicated below:

  • WBC 3000/mm3, WBC 12 000/mm3
  • Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
  • Plt 100 000/mm3
  • AST 100 IU/l
  • ALT 100 IU/l
  • T.Bil 2.0 mg/dl
  • written informed consent

Exclusion Criteria

• active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
• pregnant or breast-feeding women
• severe mental disorder
• systemic administration of corticosteroids
• unstable angina or myocardial infarction within 6 months of the trial
• unstable hypertension
• severe respiratory disease requiring continuous oxygen therapy
• previous upper abdominal surgery except laparoscopic cholecystectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open distal gastrectomy	open distal gastrectomy	open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
laparoscopy assisted distal gastrectomy	laparoscopy assisted distal gastrectomy	laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Primary Outcome Measures

Name	Time	Method
noncompliance rate	postoperative 1 week	A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping

Secondary Outcome Measures

Name	Time	Method
number of retrieved lymph nodes	postoperative 1 week
Postoperative surgical complications	postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months	Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification.
operating time	operation day	From skin incision to wound closure
time to first flatus	postoperative 1 week	the day when a patient relieve gastrointestinal gas
distal resection margin,	postoperative 1 week
unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons	postoperative 3 months	Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity.
number of retrieved lymph nodes at each stations	postoperative 1 week
proximal resection margin	postoperative 1 week
3-year disease free survival	postoperative 3 years

Trial Locations

Locations (7)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Chollanam Do, Korea, Republic of

Gyengsang National University Hospital; 🇰🇷 Jinju, Gyeongsangnam -Do, Korea, Republic of

Kyungpook national university hospital; 🇰🇷 Dae Gu, Korea, Republic of

Konyang University Hospital; 🇰🇷 Dae Jeon, Korea, Republic of

Dae Gu Veterans Hospital; 🇰🇷 Daegu, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Pusan, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of