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Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04295473
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : April 4, 2024
Sponsor:
Information provided by (Responsible Party):
Yunhong Tian, Nanchong Central Hospital

Tracking Information
First Submitted Date  ICMJE February 29, 2020
First Posted Date  ICMJE March 4, 2020
Last Update Posted Date April 4, 2024
Actual Study Start Date  ICMJE March 2, 2020
Estimated Primary Completion Date March 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • 5-year survival rate [ Time Frame: 5 years ]
    Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy
  • 3-year survival rate [ Time Frame: 3 years ]
    Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • Postoperative morbidity rate [ Time Frame: 6 months ]
    Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
  • Malnutrition rate [ Time Frame: 6 months ]
    Malnutrition rate for patients with gastrectomy after reduced port
  • Quality of life in PGSAS-45 scale [ Time Frame: 12 months ]
    The quality of life were assessed using PGSAS-45 scale for patients with gastrectomy after reduced port laparoscopic gastrectomy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduced Port Laparoscopic Gastrectomy for Gastric Cancer
Official Title  ICMJE Comparison the Short and Long-term Outcome of Patients With Gastric Cancer Who Underwent Reduced Port Laparoscopic Gastrectomy With Patients Underwent Traditional Laparoscopic Gastrectomy
Brief Summary Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy
Detailed Description Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators designed a comparative study, which sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy. The short-term outcome include surgical complications, postoperative morbidity, postoperative nutrition. The long-term outcome mainly include long-term survival.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Laparoscopic
  • Gastrectomy
Intervention  ICMJE Procedure: Reduced port laparoscopic gastrectomy
The ports were reduced in the surgery of intervention arm.
Study Arms  ICMJE
  • Experimental: Reduced port laparoscopic gastrectomy
    The definition of reduced port laparoscopic gastrectomy was 1-3 ports used in laparoscopic gastrectomy for gastric cancer.
    Intervention: Procedure: Reduced port laparoscopic gastrectomy
  • No Intervention: Standard laparoscopic gastrectomy
    5 ports were used in standard laparoscopic gastrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2020)		 160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2027
Estimated Primary Completion Date March 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
  2. Eastern Cooperative Oncology Group performance status of 0 or 1.
  3. Adequate organ function.

Exclusion Criteria:

  1. Patients had distant metastasis.
  2. oesophageal invasion of more than 3 cm.
  3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
  4. Previous chemotherapy or radiation therapy for any other malignancies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yunhong Tian, MD +86-13508087719 drtianyunhong@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04295473
Other Study ID Numbers  ICMJE 2020002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yunhong Tian, Nanchong Central Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nanchong Central Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yunhong Tian, MD Nanchong Central Hospital
PRS Account Nanchong Central Hospital
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP