Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

NCT04295473 | Recruiting

• 1 other identifier: 2020002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Laparoscopic; Gastrectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Postoperative morbidity rate

  6 months

• Malnutrition rate

  6 months

• Quality of life in PGSAS-45 scale

  12 months

Study Arms (2)

Reduced port laparoscopic gastrectomy

EXPERIMENTAL

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

Procedure: Reduced port laparoscopic gastrectomy

Standard laparoscopic gastrectomy

NO INTERVENTION

5 ports were used in standard laparoscopic gastrectomy

Interventions

Reduced port laparoscopic gastrectomy PROCEDURE

The ports were reduced in the surgery of intervention arm.

Reduced port laparoscopic gastrectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Yunhong Tian

Nanchong, Sichuan, 637000, China

RECRUITING

Study Officials

• Yunhong Tian, MD

  Nanchong Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunhong Tian, MD

CONTACT

+86-13508087719; drtianyunhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 4, 2020
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)