A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection

A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02311595

Enrollment

Registered

2014-12-08

Start date

2014-12-31

Completion date

2015-03-31

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

gastric cancer, laparoscope

Brief summary

The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible. 67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy. The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.

Interventions

PROCEDUREreduced port laparoscopic distal gastrectomy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* histologically confirmed adenocarcinoma of the stomach * Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1, * signed informed consent * location of the primary tumor in the antrum, angle and lower body * no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration

Exclusion criteria

* metastatic disease * previous history of malignancy in any organ * any co-morbidity obviating major surgery

Design outcomes

Primary

Measure	Time frame	Description
Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)	1 month after enrollment of the patients	Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping

Contacts

Primary ContactJun Ho Lee, M.D. ph.D

gsjunholee@gmail.com82-2-3410-3463

Backup ContactJieun Kim, M.D.

wldmsld.kim@samsung.com82-2-3410-1735

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026