Trials / Unknown
UnknownNCT01088204
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer
A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- National Cancer Center, Korea · Other Government
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.
Detailed description
To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | laparoscopy assisted distal gastrectomy | laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer |
| PROCEDURE | open distal gastrectomy | open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2011-12-01
- Completion
- 2016-12-01
- First posted
- 2010-03-17
- Last updated
- 2015-10-07
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01088204. Inclusion in this directory is not an endorsement.