search
Back to results

Comparison of Surgical,Clinical and Oncological Outcomes Between Robotic-assisted and Laparoscopic-assisted Gastrectomy

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Robotic-assisted Gastrectomy(RAG)
Laparoscopic-assisted Gastrectomy(LAG)
Sponsored by
wei bo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring robotic-assisted gastrectomy, laparoscopic-assisted gastrectomy, gastric cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pathologically proven gastric cancer(early or advanced).
  2. Age:older than 18 years old,younger than 80 years old.
  3. 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
  4. No obvious surgical contraindications.
  5. American Society of Anesthesiology (ASA) score class I, II, or III
  6. Written informed consent.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Robotic-assisted Gastrectomy(RAG)

    Laparoscopic-assisted Gastrectomy(LAG)

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Five-year disease free survival rate

    Secondary Outcome Measures

    Postoperative recovery course (time to first ambulation,flatus,liquid diet and soft diet,post-operative stay)
    time to first ambulation,flatus,liquid diet and soft diet,post-operative stay
    Complication (score based on the Clavien-Dindo classification system)
    Compare the incidence,type and severity of early complications after gastrectomy,score based on the Clavien-Dindo classification system.
    Mortality
    Measured as 30-day mortality rate
    Hospitalization expenses
    the cost from admission to discharge
    Quality of life
    The validated quality of life questionnaires EORTC QLQ-30 will be filled in pre-operative <5 days and post-operative at 6, 12, 24, 36, 48 and 60 months after surgery.
    Five-year overall survival rate
    Readmissions and recurrence rate
    The number of postoperative readmissions and recurrence rate.
    Operating time
    The operating time was defined as the time from skin incision to wound closure.
    Intraoperative situation (The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion)
    The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion

    Full Information

    First Posted
    April 7, 2015
    Last Updated
    May 17, 2015
    Sponsor
    wei bo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02413476
    Brief Title
    Comparison of Surgical,Clinical and Oncological Outcomes Between Robotic-assisted and Laparoscopic-assisted Gastrectomy
    Official Title
    Compared With Robotic-assisted and Laparoscopic-assisted Gastrectomy for Gastric Cancer on Surgical,Clinical and Oncological Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2018 (Anticipated)
    Study Completion Date
    May 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    wei bo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    This is a prospective study lasting 36 months. Minimally invasive gastrectomy is accepted widely in Asian countries. Laparoscopic-assisted gastrectomy offers improved early postoperative outcomes and improved long-term oncologic outcomes,but it still has its own limitations.The advantages of robotic surgery include a 3D imagine, convenient movements of the robotic arm, no tremor, and ambidextrous capability. This study therefore aimed to compare the clinical results between robotic-assisted gastrectomy(RAG) using the da Vinci Surgical System and conventional laparoscopic-assisted gastrectomy(LAG) in gastric cancer patients.To evaluate the the feasibility and safety of robotic gastrectomy and explore the patients who are more suitable for robotic gastrectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    robotic-assisted gastrectomy, laparoscopic-assisted gastrectomy, gastric cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Robotic-assisted Gastrectomy(RAG)
    Arm Type
    Experimental
    Arm Description
    Robotic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.
    Arm Title
    Laparoscopic-assisted Gastrectomy(LAG)
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.
    Intervention Type
    Procedure
    Intervention Name(s)
    Robotic-assisted Gastrectomy(RAG)
    Intervention Description
    Surgical procedure will be performed with da vinci Surgical System.The type of reconstruction will be selected according to the surgeon's experience.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic-assisted Gastrectomy(LAG)
    Intervention Description
    Surgical procedure will be performed with laparoscopic techniques.The type of reconstruction will be selected according to the surgeon's experience.
    Primary Outcome Measure Information:
    Title
    Five-year disease free survival rate
    Time Frame
    Up to 5 years post-operative
    Secondary Outcome Measure Information:
    Title
    Postoperative recovery course (time to first ambulation,flatus,liquid diet and soft diet,post-operative stay)
    Description
    time to first ambulation,flatus,liquid diet and soft diet,post-operative stay
    Time Frame
    7 days
    Title
    Complication (score based on the Clavien-Dindo classification system)
    Description
    Compare the incidence,type and severity of early complications after gastrectomy,score based on the Clavien-Dindo classification system.
    Time Frame
    30 days
    Title
    Mortality
    Description
    Measured as 30-day mortality rate
    Time Frame
    30 days
    Title
    Hospitalization expenses
    Description
    the cost from admission to discharge
    Time Frame
    30 days
    Title
    Quality of life
    Description
    The validated quality of life questionnaires EORTC QLQ-30 will be filled in pre-operative <5 days and post-operative at 6, 12, 24, 36, 48 and 60 months after surgery.
    Time Frame
    Up to 5 years post-operative
    Title
    Five-year overall survival rate
    Time Frame
    Up to 5 years post-operative
    Title
    Readmissions and recurrence rate
    Description
    The number of postoperative readmissions and recurrence rate.
    Time Frame
    Up to 5 years post-operative
    Title
    Operating time
    Description
    The operating time was defined as the time from skin incision to wound closure.
    Time Frame
    1 day
    Title
    Intraoperative situation (The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion)
    Description
    The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei bo, MD
    Phone
    +8613910038055
    Email
    weibo@vip.163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lv xiaoye, bachelor
    Phone
    +8613573196560
    Email
    lvxiaoye999@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei bo, MD
    Organizational Affiliation
    Vice director of the general surgery department, Chinese PLA General Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25670040
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25633739
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25631106
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25467019
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25434438
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25360767
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25068955
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24737464
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24695982
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24385251
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24264778
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24156033
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24083761
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24080199
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23080320
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22930489
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Comparison of Surgical,Clinical and Oncological Outcomes Between Robotic-assisted and Laparoscopic-assisted Gastrectomy

    We'll reach out to this number within 24 hrs