NCT02984787

Brief Summary

The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.

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
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2017

Typical duration for phase_3

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

December 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

December 1, 2016

Last Update Submit

December 4, 2016

Conditions

Splenic Hilum Lymph Nodes Dissection

Keywords

Gastric Cancer3D2D

Outcome Measures

Primary Outcomes (1)

  • Number of splenic hilum lymph nodes harvested

    7 days

Secondary Outcomes (9)

  • Early complication rate

    30 days

  • Operative time

    Intraoperative

  • Operative blood loss

    Intraoperative

  • Time of splenic hilum lymph nodes dissection

    Intraoperative

  • Number of total lymph nodes harvested

    7 days

  • +4 more secondary outcomes

Study Arms (2)

3D Laparoscopic total gastrectomy

EXPERIMENTAL

Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection.

Procedure: 3D Laparoscopic total gastrectomy

2D Laparoscopic total gastrectomy

ACTIVE COMPARATOR

Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection.

Procedure: 2D Laparoscopic total gastrectomy

Interventions

3D Laparoscopic total gastrectomyPROCEDURE

When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection

Also known as: 3D-LTG
3D Laparoscopic total gastrectomy
2D Laparoscopic total gastrectomyPROCEDURE

When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection

Also known as: 2D-LTG
2D Laparoscopic total gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
  • cT2-4aN0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition.
  • Eastern Cooperative Oncology Group (ECOG): 0 or 1;
  • American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
  • Written informed consent.

You may not qualify if:

  • Pregnant or breast-feeding women;
  • Severe mental disorder;
  • Previous upper abdominal surgery (except laparoscopic cholecystectomy);
  • Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
  • Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
  • Other malignant disease within the past 5 years;
  • Previous neoadjuvant chemotherapy or radiotherapy;
  • Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
  • Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Lin Chen

    the Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongqing Xi, Master

CONTACT

86-13801290395chenlinbj@sina.com

Study Design

Study Type
interventional
Phase
phase 3
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

December 1, 2016

First Posted

December 7, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

December 7, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)