CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 227 enrolled
Drug / intervention
Laparoscopic total gastrectomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03007550
NCT03007550N/ACompleted
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Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Laparoscopic And Open Total Gastrectomy In Patients With Clinical Stage I Gastric Cancer

Shanghai Zhongshan Hospital·interventional·Posted Jan 2, 2017·Updated Feb 20, 2019

In Brief

A clinical study evaluating Laparoscopic total gastrectomy and Open total gastrectomy for Gastric Cancer. Completed, enrolled 227 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2, 2017
Enrollment StartJan 4, 2017
Primary CompletionOct 24, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.5 years ago

Interventions

Laparoscopic total gastrectomyprocedure

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

Open total gastrectomyprocedure

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