Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer (LBDL)

November 17, 2016 updated by: Jin Wan, Guangdong Provincial Hospital of Traditional Chinese Medicine

Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial

To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.

Study Type

Interventional

Enrollment (Anticipated)

100

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

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
        • Contact:

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The age limits is 18-80 years old;
  2. T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.
  3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;
  4. American Society of anesthesiologists (ASA) score less than or equal to Level 3;
  5. Criteria of performance status karnofsky is greater than or equal to 60.

Exclusion Criteria:

  1. The patients' age limits is Less than 18 years old, or more than 80 years old;
  2. The preoperative imaging confirmed that the tumor involve adjacent organs;
  3. The tumor have been finding distant metastases;
  4. American Society of anesthesiologists (ASA) score more than 3;
  5. Criteria of performance status karnofsky is lower than 60;
  6. There is a laparoscopic surgery contraindications.

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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The bursectomy and D2 lymphadenectomy
Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN)
Procedure: Laparoscopic bursectomy and D2 lymphadenectomy
The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.
Active Comparator: The D2 lymphadenectomy
Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis.
Procedure: Laparoscopic D2 lymphadenectomy
D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the 3-year disease-free survival rate
Time Frame: up to 36 months
up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the operation time
Time Frame: up to 36 months
up to 36 months
the total blood loss
Time Frame: up to 36 months
up to 36 months
the number of lymph nodes dissected
Time Frame: up to 36 months
up to 36 months
the 3-year overall survival rate
Time Frame: up to 36 months
up to 36 months
the 5-year disease-free survival rate
Time Frame: up to 5 years
up to 5 years
the 5-year overall survival rate
Time Frame: up to 5 years
up to 5 years
the number of pancreatic leakage
Time Frame: up to 36 months
up to 36 months
the number of conversion to open laparotomy
Time Frame: up to 36 months
up to 36 months
the number of bowel obstruction
Time Frame: up to 36 months
up to 36 months

Other Outcome Measures

Outcome Measure
Time Frame
the time to firstly flaunt
Time Frame: up to 36 months
up to 36 months
the time of hospital stay
Time Frame: up to 36 months
up to 36 months

Collaborators and Investigators

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

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Jin Wan, professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Study Director: Liao-nan Zou, professor, Guangdong Provincial Hospital of Traditional Chinese Medicine

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

November 1, 2016

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBDL1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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