NCT02348229

Brief Summary

The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable gastric-cancer

Status
completed

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

September 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

January 17, 2015

Last Update Submit

January 27, 2015

Conditions

Keywords

Enhanced recovery after surgerylaparoscopic gastrectomyadvanced gastric cancerC-reactive,visceral proteins

Outcome Measures

Primary Outcomes (1)

  • Compartition of postoperative hospital stay

    up to 30 days after the operation

Secondary Outcomes (1)

  • Change from baseline in C-Reactive Protein( CRP) and visceral proteins level

    baseline and 5 days

Study Arms (2)

ERAS group

EXPERIMENTAL

ERAS protocols

Procedure: ERAS protocols

conventional pathway group

OTHER

using conventional pathway

Procedure: conventional pathway group

Interventions

Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery

ERAS group

No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery

conventional pathway group

Eligibility Criteria

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

You may qualify if:

  • Age 18-75 years old
  • Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
  • No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
  • No neoadjuvant chemotherapy and radiotherapy
  • No digestive obstruction and distant metastasis

You may not qualify if:

  • Conversion to open gastrectomy
  • A large amount of bleeding leading(\>500ml)
  • Patients withdrew their consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Quan Wang, Doctor

    The First Hospital of Jilin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2015

First Posted

January 28, 2015

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01