Clinical Trial for Laparoscopic D2 Gastrectomy

NCT01163812 | Completed Phase 2 DMC

• 1 other identifier: NCCCTS-2005181
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

D2 lymph node dissection

Outcome Measures

Primary Outcomes (1)

• Compliance of lymph node dissection

  noncompliance : if two or more nodal station is vacant, it is a noncompliant D2 gastrectomy.

  immediate postoperative 1 week

Secondary Outcomes (9)

• Proportion of patients with retrieved lymph nodes less than 26

  Postoperative 1 week

• operative complications

  Postoperative 1 month

• operative time

  postoperative 1 day

• estimated blood loss

  postoperative 1 day

• amount of administered analgesics

  Postoperative 1 week

Study Arms (1)

Laparoscopic D2 gastrectomy

EXPERIMENTAL

Procedure: Laparoscopic D2 distal gastrectomy

Interventions

Laparoscopic D2 distal gastrectomy PROCEDURE

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.

Also known as: LADG

Laparoscopic D2 gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang, Gyeonggido, 411-769, South Korea

Location

Related Publications (3)

• Ryu KW, Kim YW, Lee JH, Nam BH, Kook MC, Choi IJ, Bae JM. Surgical complications and the risk factors of laparoscopy-assisted distal gastrectomy in early gastric cancer. Ann Surg Oncol. 2008 Jun;15(6):1625-31. doi: 10.1245/s10434-008-9845-x. Epub 2008 Mar 14.

  PMID: 18340493 BACKGROUND

• Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.

  PMID: 17705092 RESULT

• Lee SE, Kim YW, Lee JH, Ryu KW, Cho SJ, Lee JY, Kim CG, Choi IJ, Kook MC, Nam BH, Park SR, Kim MJ, Lee JS. Developing an institutional protocol guideline for laparoscopy-assisted distal gastrectomy. Ann Surg Oncol. 2009 Aug;16(8):2231-6. doi: 10.1245/s10434-009-0490-9. Epub 2009 May 9.

  PMID: 19430842 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Young-Woo Kim, MD, PhD

  NCC Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: April 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: July 19, 2010

Record last verified: 2010-07

Locations

KR (1)