NCT02711033

Brief Summary

This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.

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
144

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Oct 2015

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

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

March 9, 2016

Last Update Submit

April 7, 2017

Conditions

Gastric CancerSplenic Hilum Lymph Nodes DissectionTotal Gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Early complication rate

    The early complication rate is defined as the event observed during operation and within 30 days after surgery.

    30 days

Secondary Outcomes (11)

  • Operative time

    Intraoperative

  • Time of splenic hilum lymph nodes dissection

    Intraoperative

  • Operative blood loss

    Intraoperative

  • Incision length

    7 days

  • Number of total lymph nodes harvested

    7 days

  • +6 more secondary outcomes

Study Arms (2)

Laparoscopic-assisted total gastrectomy

EXPERIMENTAL

Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection.

Procedure: Laparoscopic-assisted total gastrectomy

Open total gastrectomy

ACTIVE COMPARATOR

Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.

Procedure: Open total gastrectomy

Interventions

Laparoscopic-assisted total gastrectomyPROCEDURE

When patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection.

Also known as: LATG
Laparoscopic-assisted total gastrectomy
Open total gastrectomyPROCEDURE

When patients with advanced proximal gastric cancer are randomized in the open total gastrectomy (OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.

Also known as: OTG
Open total gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）
  • Informed consent
  • Eastern Cooperative Oncology Group (ECOG): 0 ot 1
  • American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ

You may not qualify if:

  • Pregnancy or female in suckling period
  • Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
  • Severe mental disease
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
  • Body mass index (BMI) \> 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Wei Wang, M.D., PH.D.

    Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Wang, M.D., PH.D.

CONTACT

+86-13922255515wangwei16400@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD.

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 17, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2018

Study Completion

April 1, 2019

Last Updated

April 10, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)