NCT03313700

Brief Summary

The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 25, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

5.3 years

First QC Date

October 10, 2017

Last Update Submit

June 21, 2023

Conditions

Stomach NeoplasmRobotic Surgery

Keywords

Stomach NeoplasmRobotic SurgeryDistal Gastrectomy

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival rate

    the rate of 3-year disease free survival

    36 months

Secondary Outcomes (19)

  • 3-year overall survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • overall postoperative morbidity rates

    30 days

  • intraoperative morbidity rates

    1 day

  • overall postoperative serious morbidity rates

    30 days

  • +14 more secondary outcomes

Study Arms (2)

Robotic Distal Gastrectomy

EXPERIMENTAL

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

Procedure: Robotic Distal Gastrectomy

Laparoscopic Distal Gastrectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic Distal Gastrectomy

Interventions

Robotic Distal GastrectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.

Robotic Distal Gastrectomy
Laparoscopic Distal GastrectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.

Laparoscopic Distal Gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Age from over 18 to under 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • expected to perform distal gastrectomy with D1+/D2 lymph node dissction to obtain R0 resection sugicall results.
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) class I to III
  • Written informed consent

You may not qualify if:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  • Gastric multiple primary carcinoma
  • Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
  • History of other malignant disease within the past 5 years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1\<50% of the predicted values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Related Publications (1)

  • Lu J, Wu D, Huang JB, Lin J, Xu BB, Xue Z, Zheng HL, Lin GS, Shen LL, Li P, Wang JB, Lin JX, Chen QY, Cao LL, Xie JW, Zheng CH, Huang CM. Comparison of robotic versus laparoscopic versus open distal gastrectomy for locally advanced gastric cancer: a prospective trial-based economic evaluation. Surg Endosc. 2023 Oct;37(10):7472-7485. doi: 10.1007/s00464-023-10147-1. Epub 2023 Jul 3.

    PMID: 37395806DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Changming Huang, Professor

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

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
Director, Head of gastric surgery, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 18, 2017

Study Start

September 25, 2017

Primary Completion

January 13, 2023

Study Completion

January 13, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

CN(1)