NCT03006263

Brief Summary

The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

5 years

First QC Date

December 26, 2016

Last Update Submit

February 4, 2020

Conditions

Stomach Neoplasms

Keywords

Stomach NeoplasmsTotally Laparoscopic Total GastrectomyLaparoscopy Assisted Total Gastrectomy

Outcome Measures

Primary Outcomes (1)

  • overall postoperative morbidity rates

    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

    30 days

Secondary Outcomes (17)

  • 3-year overall survival rate

    36 months

  • 3-year disease free survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • Intraoperative morbidity rates

    1 day

  • Time to first ambulation

    30 days

  • +12 more secondary outcomes

Study Arms (2)

Totally Laparoscopic Total Gastrectomy

EXPERIMENTAL

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

Procedure: Totally Laparoscopic Total Gastrectomy

Laparoscopy Assisted Total Gastrectomy

EXPERIMENTAL

Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.

Procedure: Laparoscopy Assisted Total Gastrectomy

Interventions

Totally Laparoscopic Total GastrectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.

Totally Laparoscopic Total Gastrectomy
Laparoscopy Assisted Total GastrectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.

Laparoscopy Assisted Total Gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Age between 18 to 75 years old
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
  • No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  • 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:

  • Pregnant and lactating women
  • Suffering from severe mental disorder
  • History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  • History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  • Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
  • 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

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,China

    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
Professor

Study Record Dates

First Submitted

December 26, 2016

First Posted

December 30, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2021

Study Completion

November 1, 2024

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share