NCT02365896

Brief Summary

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

April 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 23, 2015

Last Update Submit

April 24, 2015

Conditions

Total Laparoscopic Distal GastrectomyLocally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • postoperative early anastomotic morbidity

    30 days

Secondary Outcomes (6)

  • Flatus time

    7 days

  • Quality of life

    30 days

  • Postoperative hospital stay

    30 days

  • Pain score

    10 days

  • Postoperative inflammation response

    10 days

  • +1 more secondary outcomes

Study Arms (1)

TLDG or LADG

OTHER

To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG

Procedure: TLDG or LADG

Interventions

TLDG or LADGPROCEDURE
TLDG or LADG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnosis of gastric cancer was confirmed by pathological examination
  • Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th
  • No accompany with another cancer
  • ECOG 0-1
  • ASA I-III
  • Agreement

You may not qualify if:

  • Pregnant or suckling period
  • Patients with a history of preoperative chemoradiotherapy
  • Patients with unable to finish D2 lymphadenectomy or R0 resection
  • Laparoscopic surgery contraindications
  • Serious organ disfunction
  • Accompany with serious mental disease
  • Continuous treatment with steroid in 1 month
  • Disagreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Ikeda O, Sakaguchi Y, Aoki Y, Harimoto N, Taomoto J, Masuda T, Ohga T, Adachi E, Toh Y, Okamura T, Baba H. Advantages of totally laparoscopic distal gastrectomy over laparoscopically assisted distal gastrectomy for gastric cancer. Surg Endosc. 2009 Oct;23(10):2374-9. doi: 10.1007/s00464-009-0360-3. Epub 2009 Mar 5.

    PMID: 19263143BACKGROUND

  • Han G, Park JY, Kim YJ. Comparison of short-term postoperative outcomes in totally laparoscopic distal gastrectomy versus laparoscopy-assisted distal gastrectomy. J Gastric Cancer. 2014 Jun;14(2):105-10. doi: 10.5230/jgc.2014.14.2.105. Epub 2014 Jun 30.

    PMID: 25061537BACKGROUND

  • Oki E, Sakaguchi Y, Ohgaki K, Saeki H, Chinen Y, Minami K, Sakamoto Y, Toh Y, Kusumoto T, Maehara Y. Feasibility of delta-shaped anastomoses in totally laparoscopic distal gastrectomy. Eur Surg Res. 2011;47(4):205-10. doi: 10.1159/000332850. Epub 2011 Oct 13.

    PMID: 22004901BACKGROUND

  • Kim BS, Yook JH, Choi YB, Kim KC, Kim MG, Kim TH, Kawada H, Kim BS. Comparison of early outcomes of intracorporeal and extracorporeal gastroduodenostomy after laparoscopic distal gastrectomy for gastric cancer. J Laparoendosc Adv Surg Tech A. 2011 Jun;21(5):387-91. doi: 10.1089/lap.2010.0515. Epub 2011 May 11.

    PMID: 21561328BACKGROUND

  • Kim MG, Kim KC, Kim BS, Kim TH, Kim HS, Yook JH, Kim BS. A totally laparoscopic distal gastrectomy can be an effective way of performing laparoscopic gastrectomy in obese patients (body mass index>/=30). World J Surg. 2011 Jun;35(6):1327-32. doi: 10.1007/s00268-011-1034-6.

    PMID: 21424875BACKGROUND

  • Lee J, Kim D, Kim W. Comparison of laparoscopy-assisted and totally laparoscopic Billroth-II distal gastrectomy for gastric cancer. J Korean Surg Soc. 2012 Mar;82(3):135-42. doi: 10.4174/jkss.2012.82.3.135. Epub 2012 Feb 27.

    PMID: 22403746BACKGROUND

  • Woo J, Lee JH, Shim KN, Jung HK, Lee HM, Lee HK. Does the Difference of Invasiveness between Totally Laparoscopic Distal Gastrectomy and Laparoscopy-Assisted Distal Gastrectomy Lead to a Difference in Early Surgical Outcomes? A Prospective Randomized Trial. Ann Surg Oncol. 2015;22(6):1836-43. doi: 10.1245/s10434-014-4229-x. Epub 2014 Nov 14.

    PMID: 25395149BACKGROUND

  • Song KY, Park CH, Kang HC, Kim JJ, Park SM, Jun KH, Chin HM, Hur H. Is totally laparoscopic gastrectomy less invasive than laparoscopy-assisted gastrectomy?: prospective, multicenter study. J Gastrointest Surg. 2008 Jun;12(6):1015-21. doi: 10.1007/s11605-008-0484-0. Epub 2008 Feb 7.

    PMID: 18256884BACKGROUND

Central Study Contacts

Weidong Zang, Associate chief physician

CONTACT

13600815361fjzangwd@163.com

Wenhao Teng, Doctor

CONTACT

tengwh@yeah.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2015

First Posted

February 19, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2017

Last Updated

April 27, 2015

Record last verified: 2015-01