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Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Laparoscopic Gastrectomy Procedure: Reduced port laparoscopic gastrectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison the Short and Long-term Outcome of Patients With Gastric Cancer Who Underwent Reduced Port Laparoscopic Gastrectomy With Patients Underwent Traditional Laparoscopic Gastrectomy
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 1, 2027
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Reduced port laparoscopic gastrectomy
The definition of reduced port laparoscopic gastrectomy was 1-3 ports used in laparoscopic gastrectomy for gastric cancer.
 Procedure: Reduced port laparoscopic gastrectomy
The ports were reduced in the surgery of intervention arm.
No Intervention: Standard laparoscopic gastrectomy
5 ports were used in standard laparoscopic gastrectomy


Outcome Measures
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Primary Outcome Measures :
  1. 5-year survival rate [ Time Frame: 5 years ]
    Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy

  2. 3-year survival rate [ Time Frame: 3 years ]
    Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy


Secondary Outcome Measures :
  1. Postoperative morbidity rate [ Time Frame: 6 months ]
    Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy

  2. Malnutrition rate [ Time Frame: 6 months ]
    Malnutrition rate for patients with gastrectomy after reduced port

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295473


Contacts
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Contact: Yunhong Tian, MD +86-13508087719 drtianyunhong@126.com

Locations
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China, Sichuan
Yunhong Tian Recruiting
Nanchong, Sichuan, China, 637000
Contact: Yunhong Tian, Doctor    +8613508087719    drtianyunhong@126.com   
Sponsors and Collaborators
Nanchong Central Hospital
Investigators
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Principal Investigator: Yunhong Tian, MD Nanchong Central Hospital
More Information
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Responsible Party: Yunhong Tian, Professor, Nanchong Central Hospital
ClinicalTrials.gov Identifier: NCT04295473    
Other Study ID Numbers: 2020002
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases