A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection

Gastric Cancer Clinical Trial

Official title:

A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02311595
• Other study ID #: 2014-10-032
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 4, 2014
• Last updated: December 5, 2014
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: December 2014
• Source: Samsung Medical Center
• Contact: Jun Ho Lee, M.D. ph.D
• Phone: 82-2-3410-3463
• Email: gsjunholee[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.

67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.

The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 67
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• histologically confirmed adenocarcinoma of the stomach

• Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 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

Exclusion Criteria:

• metastatic disease

• previous history of malignancy in any organ

• any co-morbidity obviating major surgery

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• reduced port laparoscopic distal gastrectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

References & Publications (3)

Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. — View Citation

Kim SM, Lee JH, Lee SH, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S. Techniques of reduced PRT laparoscopy-assisted distal gastrectomy (duet LADG). Ann Surg Oncol. 2015 Mar;22(3):793. doi: 10.1245/s10434-014-4087-6. Epub 2014 Sep 17. — View Citation

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. Epub 2007 Aug 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)	Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping	1 month after enrollment of the patients	No