Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

Comparison the Short and Long-term Outcome of Patients With Gastric Cancer Who Underwent Reduced Port Laparoscopic Gastrectomy With Patients Underwent Traditional Laparoscopic Gastrectomy

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

Study Overview

• Status: Recruiting
• Conditions: Gastrectomy; Laparoscopic
• Intervention / Treatment: Procedure: Reduced port 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: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunhong Tian, MD; Phone Number: +86-13508087719; Email: drtianyunhong@126.com

Study Locations

• China
  • Sichuan
    • Nanchong, Sichuan, China, 637000
      • Recruiting
      • Yunhong Tian
      • Contact: Yunhong Tian, Doctor; Phone Number: +8613508087719; Email: drtianyunhong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year survival rate	Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy	5 years
3-year survival rate	Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morbidity rate	Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy	6 months
Malnutrition rate	Malnutrition rate for patients with gastrectomy after reduced port	6 months
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.	12 months

Collaborators and Investigators

• Sponsor: Nanchong Central Hospital
• Investigators: Principal Investigator: Yunhong Tian, MD, Nanchong Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 29, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2020002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No