NCT04795063

Brief Summary

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
8mo left

Started Mar 2021

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress89%
Mar 2021Jan 2027

Study Start

First participant enrolled

March 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

March 4, 2021

Last Update Submit

March 10, 2021

Conditions

Gastric CancerRobotic Gastrectomy

Keywords

Gastric Cancerrobotic assisted distal gastrectomytotal robotic distal gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Morbidity rates

    This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.

    30 days

Secondary Outcomes (10)

  • 3-year disease free survival rate

    36 months

  • 3-year overall survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • intraoperative morbidity rates

    1 day

  • overall postoperative serious morbidity rates

    30 days

  • +5 more secondary outcomes

Study Arms (2)

Total Robotic Distal Gastrectomy

EXPERIMENTAL

After exploration and randomization, patients received total robotic distal gastrectomy

Procedure: Total Robotic Distal Gastrectomy

Robotic-Assisted Distal Gastrectomy

ACTIVE COMPARATOR

After exploration and randomization, patients received robotic-assisted distal gastrectomy.

Procedure: Robotic-Assisted Distal Gastrectomy

Interventions

Total Robotic Distal GastrectomyPROCEDURE

All the surgical procedures are performed using the robot system.

Total Robotic Distal Gastrectomy
Robotic-Assisted Distal GastrectomyPROCEDURE

After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.

Robotic-Assisted 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 dissection to obtain R0 resection surgicall results.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • American Society of Anesthesiology (ASA) 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 Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) 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
  • Forced expiratory volume in 1 second (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, 350001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Chang-ming Huang, MD

    Fujian Medical University Union Hospital

    STUDY CHAIR

Central Study Contacts

Chang-ming Huang, MD

CONTACT

+86-13805069676hcmlr2002@163.com

Qi-yue Chen, PhD

CONTACT

+86-15980235636690934662@qq.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
Professor

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 12, 2021

Study Start

March 1, 2021

Primary Completion

January 1, 2024

Study Completion (Estimated)

January 1, 2027

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations

CN(1)