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

NCT02311595 | Unknown Phase 2

• 1 other identifier: 2014-10-032
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer

Keywords

gastric cancer; laparoscope

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

reduced port

EXPERIMENTAL

gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection

Procedure: reduced port laparoscopic distal gastrectomy

Interventions

reduced port laparoscopic distal gastrectomy PROCEDURE

reduced port

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• metastatic disease
• previous history of malignancy in any organ
• any co-morbidity obviating major surgery

Sponsors & Collaborators

• Samsung Medical Center: lead

Related Publications (3)

• 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 BACKGROUND

• 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.

  PMID: 25227307 BACKGROUND

• 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. doi: 10.1056/NEJM199903253401202.

  PMID: 10089184 BACKGROUND

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

• Jun Ho Lee, M.D. ph.D

  Samsung Medical Center

  STUDY CHAIR

Central Study Contacts

Jun Ho Lee, M.D. ph.D

CONTACT

82-2-3410-3463; gsjunholee@gmail.com

Jieun Kim, M.D.

CONTACT

82-2-3410-1735; wldmsld.kim@samsung.com

Study Design

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

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 8, 2014

Record last verified: 2014-12