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Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

Primary Purpose

Laparoscopic, Gastrectomy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Reduced port laparoscopic gastrectomy
Sponsored by
Nanchong Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yunhong TianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reduced port laparoscopic gastrectomy

Standard laparoscopic gastrectomy

Arm Description

The definition of reduced port laparoscopic gastrectomy was 1-3 ports used in laparoscopic gastrectomy for gastric cancer.

5 ports were used in standard laparoscopic gastrectomy

Outcomes

Primary Outcome Measures

5-year survival rate
Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy
3-year survival rate
Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy

Secondary Outcome Measures

Postoperative morbidity rate
Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
Malnutrition rate
Malnutrition rate for patients with gastrectomy after reduced port
Quality of life in PGSAS-45 scale
The quality of life were assessed using PGSAS-45 scale for patients with gastrectomy after reduced port laparoscopic gastrectomy.

Full Information

First Posted
February 29, 2020
Last Updated
June 17, 2023
Sponsor
Nanchong Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04295473
Brief Title
Reduced Port Laparoscopic Gastrectomy for Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanchong Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic, Gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reduced port laparoscopic gastrectomy
Arm Type
Experimental
Arm Description
The definition of reduced port laparoscopic gastrectomy was 1-3 ports used in laparoscopic gastrectomy for gastric cancer.
Arm Title
Standard laparoscopic gastrectomy
Arm Type
No Intervention
Arm Description
5 ports were used in standard laparoscopic gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Reduced port laparoscopic gastrectomy
Intervention Description
The ports were reduced in the surgery of intervention arm.
Primary Outcome Measure Information:
Title
5-year survival rate
Description
Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy
Time Frame
5 years
Title
3-year survival rate
Description
Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Postoperative morbidity rate
Description
Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
Time Frame
6 months
Title
Malnutrition rate
Description
Malnutrition rate for patients with gastrectomy after reduced port
Time Frame
6 months
Title
Quality of life in PGSAS-45 scale
Description
The quality of life were assessed using PGSAS-45 scale for patients with gastrectomy after reduced port laparoscopic gastrectomy.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages. Eastern Cooperative Oncology Group performance status of 0 or 1. Adequate organ function. Exclusion Criteria: Patients had distant metastasis. oesophageal invasion of more than 3 cm. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma. Previous chemotherapy or radiation therapy for any other malignancies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunhong Tian, MD
Phone
+86-13508087719
Email
drtianyunhong@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunhong Tian, MD
Organizational Affiliation
Nanchong Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yunhong Tian
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhong Tian, Doctor
Phone
+8613508087719
Email
drtianyunhong@126.com

12. IPD Sharing Statement

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Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

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