NCT04010006

Brief Summary

The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

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
502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

May 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

May 9, 2019

Last Update Submit

January 3, 2020

Conditions

Stomach Neoplasms

Keywords

Stomach NeoplasmsLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • operating time

    day

    1 day

Secondary Outcomes (19)

  • The number of lymph node dissection

    1 day

  • the number of positive lymph nodes

    1 day

  • intraoperative lymph node dissection time

    1 day

  • intracavitary anastomosis time

    1 day

  • intraoperative blood loss

    1 day

  • +14 more secondary outcomes

Study Arms (2)

4K Laparoscopic Surgery

EXPERIMENTAL

4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Procedure: 4K Laparoscopic Surgery

HD Laparoscopic Surgery

ACTIVE COMPARATOR

HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Procedure: HD Laparoscopic Surgery

Interventions

4K Laparoscopic SurgeryPROCEDURE

4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

4K Laparoscopic Surgery
HD Laparoscopic SurgeryPROCEDURE

HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

HD Laparoscopic Surgery

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1)Age from over 19 to under 74 years
  • (2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • (3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications
  • (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
  • (5)American Society of Anesthesiology (ASA) score class I, II, or III
  • (6)Written informed consent

You may not qualify if:

  • (1)Women during pregnancy or breast-feeding
  • (2)Severe mental disorder
  • (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
  • (5)History of unstable angina or myocardial infarction within past six months
  • (6)History of cerebrovascular accident within past six months
  • (7)History of continuous systematic administration of corticosteroids within one month
  • (8)History of previous neoadjuvant chemotherapy or radiotherapy
  • (9)T4b tumors
  • (10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • (11)FEV1(Forced expiratory volume in one second)#50% of predicted values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Changming Huang Huang

    Fujian Medical University Union Hospital

    STUDY CHAIR

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

May 9, 2019

First Posted

July 8, 2019

Study Start

July 15, 2019

Primary Completion

July 15, 2020

Study Completion

July 15, 2023

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)