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Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer

NCT03007550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2019-02-20

No results posted yet for this study

Summary

This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Conditions

Interventions

PROCEDURE

Laparoscopic total gastrectomy

LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma

PROCEDURE

Open total gastrectomy

OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Yihong Sun, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2018-10-24
Completion
2018-10-24

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03007550 on ClinicalTrials.gov