Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

Gastrectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295473
• Other study ID #: 2020002
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2024
• Source: Nanchong Central Hospital
• Contact: Yunhong Tian, MD
• Phone: +86-13508087719
• Email: drtianyunhong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrectomy
• Laparoscopic
• Stomach Neoplasms

Intervention

Procedure:
• Reduced port laparoscopic gastrectomy
The ports were reduced in the surgery of intervention arm.

Locations

Country	Name	City	State
China	Yunhong Tian	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Nanchong Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year survival rate	Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy	5 years
Primary	3-year survival rate	Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy	3 years
Secondary	Postoperative morbidity rate	Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy	6 months
Secondary	Malnutrition rate	Malnutrition rate for patients with gastrectomy after reduced port	6 months
Secondary	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