Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

NCT ID: NCT04010006

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2023-07-15

Brief Summary

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The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

Detailed Description

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A prospective randomized comparison of HD and 4K laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 4K laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4K Laparoscopic Surgery

4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Group Type EXPERIMENTAL

4K Laparoscopic Surgery

Intervention Type PROCEDURE

4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

HD Laparoscopic Surgery

HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Group Type ACTIVE_COMPARATOR

HD Laparoscopic Surgery

Intervention Type PROCEDURE

HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Interventions

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4K Laparoscopic Surgery

4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Intervention Type PROCEDURE

HD Laparoscopic Surgery

HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* (1)Age from over 19 to under 74 years
* (2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* (3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications
* (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
* (5)American Society of Anesthesiology (ASA) score class I, II, or III
* (6)Written informed consent

Exclusion Criteria

* (1)Women during pregnancy or breast-feeding
* (2)Severe mental disorder
* (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
* (5)History of unstable angina or myocardial infarction within past six months
* (6)History of cerebrovascular accident within past six months
* (7)History of continuous systematic administration of corticosteroids within one month
* (8)History of previous neoadjuvant chemotherapy or radiotherapy
* (9)T4b tumors
* (10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* (11)FEV1(Forced expiratory volume in one second)#50% of predicted values
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chang-Ming Huang, Prof.

Director, Head of gastric surgery, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Changming Huang Huang

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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FUGES-017

Identifier Type: -

Identifier Source: org_study_id

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