NCT03273920

Brief Summary

This study is an investigator-initiated, randomized, controlled, parallel group, and non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,110

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

14 active sites

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

August 23, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2022

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

August 23, 2017

Last Update Submit

September 5, 2017

Conditions

Gastric Cancer

Keywords

laparoscopy-assisted gastrectomyrobot-assisted gastrectomyadvanced gastric cancerD2 Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • 3-year relapse-free survival

    Relapse-free survival is defined as days from surgery to recurrence or death from any cause, and it is censored at the latest day when the patient is alive without any evidence of recurrence.

    3 years

Secondary Outcomes (7)

  • Morbidity

    30 days

  • Mortality

    30 days

  • 3-year overall survival

    3 years

  • 3-year recurrence pattern

    3 years

  • Postoperative recovery course

    15 days

  • +2 more secondary outcomes

Study Arms (2)

Robotic gastrectomy

EXPERIMENTAL

Robotic distal gastrectomy with D2 nodal dissection

Procedure: Robotic distal gastrectomy with D2 nodal dissection

Laparoscopic gastrectomy

ACTIVE COMPARATOR

Laparoscopic distal gastrectomy with D2 nodal dissection

Procedure: Laparoscopic distal gastrectomy with D2 nodal dissection

Interventions

Robotic distal gastrectomy with D2 nodal dissectionPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.

Robotic gastrectomy
Laparoscopic distal gastrectomy with D2 nodal dissectionPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.

Laparoscopic gastrectomy

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven gastric adenocarcinoma.
  • Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.
  • Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • American Society of Anesthesiology (ASA) score of class I to III
  • Patients who freely give informed consent to participate in the clinical study

You may not qualify if:

  • Previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)
  • Gastric cancer-related complications (complete obstruction or perforation)
  • Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging
  • Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer
  • Patients diagnosed with other malignancy within 5 years
  • Severe mental disorder
  • Unstable angina or myocardial infarction within the past 6 months
  • Cerebrovascular accident within the past 6 months
  • Severe respiratory disease (FEV1\< 50%)
  • Continuous systemic steroid therapy within 1 month before the study
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

Location

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Location

Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Lanzhou PLA General Hospital

Lanzhou, Gansu, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Nanjing General Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Xijing Hospital of Digestive Dieases

Xi’an, Shanxi, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Related Publications (12)

  • Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.

    PMID: 8180768BACKGROUND

  • Zhao Y, Yu P, Hao Y, Qian F, Tang B, Shi Y, Luo H, Zhang Y. Comparison of outcomes for laparoscopically assisted and open radical distal gastrectomy with lymphadenectomy for advanced gastric cancer. Surg Endosc. 2011 Sep;25(9):2960-6. doi: 10.1007/s00464-011-1652-y. Epub 2011 Apr 22.

    PMID: 21512884BACKGROUND

  • Hu Y, Ying M, Huang C, Wei H, Jiang Z, Peng X, Hu J, Du X, Wang B, Lin F, Xu J, Dong G, Mou T, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Oncologic outcomes of laparoscopy-assisted gastrectomy for advanced gastric cancer: a large-scale multicenter retrospective cohort study from China. Surg Endosc. 2014 Jul;28(7):2048-56. doi: 10.1007/s00464-014-3426-9. Epub 2014 Mar 21.

    PMID: 24651893BACKGROUND

  • Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.

    PMID: 26903580BACKGROUND

  • Inaki N, Etoh T, Ohyama T, Uchiyama K, Katada N, Koeda K, Yoshida K, Takagane A, Kojima K, Sakuramoto S, Shiraishi N, Kitano S. A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901). World J Surg. 2015 Nov;39(11):2734-41. doi: 10.1007/s00268-015-3160-z.

    PMID: 26170158BACKGROUND

  • Hashizume M, Shimada M, Tomikawa M, Ikeda Y, Takahashi I, Abe R, Koga F, Gotoh N, Konishi K, Maehara S, Sugimachi K. Early experiences of endoscopic procedures in general surgery assisted by a computer-enhanced surgical system. Surg Endosc. 2002 Aug;16(8):1187-91. doi: 10.1007/s004640080154. Epub 2002 May 3.

    PMID: 11984681BACKGROUND

  • 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

  • Nakauchi M, Suda K, Susumu S, Kadoya S, Inaba K, Ishida Y, Uyama I. Comparison of the long-term outcomes of robotic radical gastrectomy for gastric cancer and conventional laparoscopic approach: a single institutional retrospective cohort study. Surg Endosc. 2016 Dec;30(12):5444-5452. doi: 10.1007/s00464-016-4904-z. Epub 2016 Apr 29.

    PMID: 27129542BACKGROUND

  • Obama K, Kim YM, Kang DR, Son T, Kim HI, Noh SH, Hyung WJ. Long-term oncologic outcomes of robotic gastrectomy for gastric cancer compared with laparoscopic gastrectomy. Gastric Cancer. 2018 Mar;21(2):285-295. doi: 10.1007/s10120-017-0740-7. Epub 2017 Jun 21.

    PMID: 28639136BACKGROUND

  • Duan BS, Zhao J, Xie LF, Wang Y. Robotic Verse Laparoscopic Gastrectomy for Gastric Cancer: A Pooled Analysis of 11 Individual Studies. Surg Laparosc Endosc Percutan Tech. 2017 Jun;27(3):147-153. doi: 10.1097/SLE.0000000000000410.

    PMID: 28582378BACKGROUND

  • Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.

    PMID: 26020107BACKGROUND

  • Park JM, Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Hyung WJ, Ryu KW. Who may benefit from robotic gastrectomy?: A subgroup analysis of multicenter prospective comparative study data on robotic versus laparoscopic gastrectomy. Eur J Surg Oncol. 2016 Dec;42(12):1944-1949. doi: 10.1016/j.ejso.2016.07.012. Epub 2016 Jul 29.

    PMID: 27514719BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Peiwu Yu, M.D.

    Southwest Hospital, China

    STUDY CHAIR

Central Study Contacts

Peiwu Yu, M.D.

CONTACT

+86023-68754161yupeiwu01@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 6, 2017

Study Start

September 25, 2017

Primary Completion

September 25, 2019

Study Completion

September 25, 2022

Last Updated

September 8, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(14)