Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

April 24, 2015 updated by: Fujian Cancer Hospital
Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Weidong Zang, Associate chief physician
  • Phone Number: 13600815361
  • Email: fjzangwd@163.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The diagnosis of gastric cancer was confirmed by pathological examination
  • Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th
  • No accompany with another cancer
  • ECOG 0-1
  • ASA I-III
  • Agreement

Exclusion Criteria:

  • Pregnant or suckling period
  • Patients with a history of preoperative chemoradiotherapy
  • Patients with unable to finish D2 lymphadenectomy or R0 resection
  • Laparoscopic surgery contraindications
  • Serious organ disfunction
  • Accompany with serious mental disease
  • Continuous treatment with steroid in 1 month
  • Disagreement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TLDG or LADG
To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG
Procedure: TLDG or LADG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative early anastomotic morbidity
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flatus time
Time Frame: 7 days
7 days
Quality of life
Time Frame: 30 days
estimated with EORTC QLQ-C30V3、EORTC QLQ-STO22
30 days
Postoperative hospital stay
Time Frame: 30 days
30 days
Pain score
Time Frame: 10 days
10 days
Postoperative inflammation response
Time Frame: 10 days
using C-reactive protein、IL-6、WBC and so on postoperative 1,3,5,7 days
10 days
Nutrition
Time Frame: 30 days
NRS-2002 and PG-SGA in 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Estimate)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLDG vs. LADG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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