NCT02413476

Brief Summary

The study aims to compare the clinical outcomes between robotic-assisted and laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who are more suitable for robotic gastrectomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started May 2015

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

April 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 19, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

April 7, 2015

Last Update Submit

May 17, 2015

Conditions

Gastric Cancer

Keywords

robotic-assisted gastrectomylaparoscopic-assisted gastrectomygastric cancer

Outcome Measures

Primary Outcomes (1)

  • Five-year disease free survival rate

    Up to 5 years post-operative

Secondary Outcomes (9)

  • Postoperative recovery course (time to first ambulation,flatus,liquid diet and soft diet,post-operative stay)

    7 days

  • Complication (score based on the Clavien-Dindo classification system)

    30 days

  • Mortality

    30 days

  • Hospitalization expenses

    30 days

  • Quality of life

    Up to 5 years post-operative

  • +4 more secondary outcomes

Study Arms (2)

Robotic-assisted Gastrectomy(RAG)

EXPERIMENTAL

Robotic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.

Procedure: Robotic-assisted Gastrectomy(RAG)

Laparoscopic-assisted Gastrectomy(LAG)

ACTIVE COMPARATOR

Laparoscopic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.

Procedure: Laparoscopic-assisted Gastrectomy(LAG)

Interventions

Robotic-assisted Gastrectomy(RAG)PROCEDURE

Surgical procedure will be performed with da vinci Surgical System.The type of reconstruction will be selected according to the surgeon's experience.

Robotic-assisted Gastrectomy(RAG)
Laparoscopic-assisted Gastrectomy(LAG)PROCEDURE

Surgical procedure will be performed with laparoscopic techniques.The type of reconstruction will be selected according to the surgeon's experience.

Laparoscopic-assisted Gastrectomy(LAG)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven gastric cancer(early or advanced).
  • Age:older than 18 years old,younger than 80 years old.
  • cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition
  • No obvious surgical contraindications.
  • American Society of Anesthesiology (ASA) score class I, II, or III
  • Written informed consent.

You may not qualify if:

  • Severe mental disorder
  • Pregnancy
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection.
  • History of unstable angina or myocardial infarction within past six months
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of other malignant disease within past 5 years.
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • Any accompanying surgical condition needed to be performed in the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4.

    PMID: 25670040BACKGROUND

  • Parisi A, Desiderio J. Establishing a multi-institutional registry to compare the outcomes of robotic, laparoscopic, and open surgery for gastric cancer. Surgery. 2015 Apr;157(4):830-1. doi: 10.1016/j.surg.2014.12.007. Epub 2015 Jan 26. No abstract available.

    PMID: 25633739BACKGROUND

  • Lee J, Kim YM, Woo Y, Obama K, Noh SH, Hyung WJ. Robotic distal subtotal gastrectomy with D2 lymphadenectomy for gastric cancer patients with high body mass index: comparison with conventional laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy. Surg Endosc. 2015 Nov;29(11):3251-60. doi: 10.1007/s00464-015-4069-1. Epub 2015 Jan 29.

    PMID: 25631106BACKGROUND

  • Chuan L, Yan S, Pei-Wu Y. Meta-analysis of the short-term outcomes of robotic-assisted compared to laparoscopic gastrectomy. Minim Invasive Ther Allied Technol. 2015 Jun;24(3):127-34. doi: 10.3109/13645706.2014.985685. Epub 2014 Dec 3.

    PMID: 25467019BACKGROUND

  • Suda K, Ishida Y, Uyama I. [Current status of robotic surgery for gastric cancer]. Gan To Kagaku Ryoho. 2014 Nov;41(11):1358-61. Japanese.

    PMID: 25434438BACKGROUND

  • Huang KH, Lan YT, Fang WL, Chen JH, Lo SS, Li AF, Chiou SH, Wu CW, Shyr YM. Comparison of the operative outcomes and learning curves between laparoscopic and robotic gastrectomy for gastric cancer. PLoS One. 2014 Oct 31;9(10):e111499. doi: 10.1371/journal.pone.0111499. eCollection 2014.

    PMID: 25360767BACKGROUND

  • Zong L, Seto Y, Aikou S, Takahashi T. Efficacy evaluation of subtotal and total gastrectomies in robotic surgery for gastric cancer compared with that in open and laparoscopic resections: a meta-analysis. PLoS One. 2014 Jul 28;9(7):e103312. doi: 10.1371/journal.pone.0103312. eCollection 2014.

    PMID: 25068955BACKGROUND

  • Roviello F, Piagnerelli R, Ferrara F, Caputo E, Scheiterle M, Marrelli D. Assessing the feasibility of full robotic interaortocaval nodal dissection for locally advanced gastric cancer. Int J Med Robot. 2015 Jun;11(2):218-22. doi: 10.1002/rcs.1588. Epub 2014 Apr 15.

    PMID: 24737464BACKGROUND

  • Son T, Lee JH, Kim YM, Kim HI, Noh SH, Hyung WJ. Robotic spleen-preserving total gastrectomy for gastric cancer: comparison with conventional laparoscopic procedure. Surg Endosc. 2014 Sep;28(9):2606-15. doi: 10.1007/s00464-014-3511-0. Epub 2014 Apr 3.

    PMID: 24695982BACKGROUND

  • Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.

    PMID: 24385251BACKGROUND

  • Hyun MH, Lee CH, Kim HJ, Tong Y, Park SS. Systematic review and meta-analysis of robotic surgery compared with conventional laparoscopic and open resections for gastric carcinoma. Br J Surg. 2013 Nov;100(12):1566-78. doi: 10.1002/bjs.9242.

    PMID: 24264778BACKGROUND

  • Marano A, Choi YY, Hyung WJ, Kim YM, Kim J, Noh SH. Robotic versus Laparoscopic versus Open Gastrectomy: A Meta-Analysis. J Gastric Cancer. 2013 Sep;13(3):136-48. doi: 10.5230/jgc.2013.13.3.136. Epub 2013 Sep 30.

    PMID: 24156033BACKGROUND

  • Liao GX, Xie GZ, Li R, Zhao ZH, Sun QQ, Du SS, Ren C, Li GX, Deng HJ, Yuan YW. Meta-analysis of outcomes compared between robotic and laparoscopic gastrectomy for gastric cancer. Asian Pac J Cancer Prev. 2013;14(8):4871-5. doi: 10.7314/apjcp.2013.14.8.4871.

    PMID: 24083761BACKGROUND

  • Kim HI, Park MS, Song KJ, Woo Y, Hyung WJ. Rapid and safe learning of robotic gastrectomy for gastric cancer: multidimensional analysis in a comparison with laparoscopic gastrectomy. Eur J Surg Oncol. 2014 Oct;40(10):1346-54. doi: 10.1016/j.ejso.2013.09.011. Epub 2013 Sep 17.

    PMID: 24080199BACKGROUND

  • Hyun MH, Lee CH, Kwon YJ, Cho SI, Jang YJ, Kim DH, Kim JH, Park SH, Mok YJ, Park SS. Robot versus laparoscopic gastrectomy for cancer by an experienced surgeon: comparisons of surgery, complications, and surgical stress. Ann Surg Oncol. 2013 Apr;20(4):1258-65. doi: 10.1245/s10434-012-2679-6. Epub 2012 Oct 19.

    PMID: 23080320BACKGROUND

  • Ortiz-Oshiro E, Exposito PB, Sierra JM, Gonzalez JD, Barbosa DS, Fernandez-Represa JA. Laparoscopic and robotic distal gastrectomy for gastrointestinal stromal tumour: case report. Int J Med Robot. 2012 Dec;8(4):491-5. doi: 10.1002/rcs.1456. Epub 2012 Aug 29.

    PMID: 22930489BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Wei bo, MD

    Vice director of the general surgery department, Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Wei bo, MD

CONTACT

+8613910038055weibo@vip.163.com

Lv xiaoye, bachelor

CONTACT

+8613573196560lvxiaoye999@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Director of the general surgery department, Chinese PLA General Hospital

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 19, 2015

Record last verified: 2015-04