Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

Sponsor
Nanchong Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04295473
Collaborator
(none)
160
1
2
83.9
1.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Reduced port laparoscopic gastrectomy
N/A

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

Study Type:
Interventional
Anticipated 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 :
Mar 2, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

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

Primary Outcome Measures

  1. 5-year survival rate [5 years]

    Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy

  2. 3-year survival rate [3 years]

    Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy

Secondary Outcome Measures

  1. Postoperative morbidity rate [6 months]

    Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy

  2. Malnutrition rate [6 months]

    Malnutrition rate for patients with gastrectomy after reduced port

  3. Quality of life in PGSAS-45 scale [12 months]

    The quality of life were assessed using PGSAS-45 scale for patients with gastrectomy after reduced port laparoscopic gastrectomy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Yunhong Tian Nanchong Sichuan China 637000

Sponsors and Collaborators

  • Nanchong Central Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yunhong Tian, Professor, Nanchong Central Hospital
ClinicalTrials.gov Identifier:
NCT04295473
Other Study ID Numbers:
  • 2020002
First Posted:
Mar 4, 2020
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2022