Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).
20 Years
80 Years
Both
Stomach Neoplasm
Trial Information
Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).
In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy)
and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of
splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be
performed basically. As a general rule, Billroth II method will be used for gastric
reconstruction for all cases.Billroth II gastrectomy is to link the gastric pouch to the
jejunum 10~15 cm distal to the ligament of Treitz. An antecolic or retrocolic
gastrojejunostomy connects the jejunum to the stomach in one continuous segment. For
anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube
is inserted through the right flank area and additional drainage tubes can be inserted as
needed.
Inclusion Criteria:
- Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
- Age: older than 20 year old, younger than 80 year old
- Cancer core: located at the middle or lower part of stomach
- Preoperative cancer stage (CT, GFS stage): cT2N0M0, cT2aN1M0, cT2bN1M0, cT3N0M0
- ASA score: ≤ 3
- Informed consent patients (explanation about our clinical trials is provided to the
patients or patrons, if patient is not available)
Exclusion Criteria:
- Concurrent cancer patients or patient who was treated due to other types of cancer
before the patient was diagnosed as a gastric cancer patient
- Patient who was treated by other types of treatment methods, such as chemotherapy,
immunotherapy, or radiotherapy
- Patient who was received upper abdominal surgery (except, laparoscopic
cholecystectomy)
- Patient who was treated because of systemic inflammatory disease
- Pregnant patient
- Patient who suffer from bleeding tendency disease, such as hemophilia or patient
taking anti-coagulant medication due to deep vein thrombosis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
2 year survival
Outcome Time Frame:
two year
Safety Issue:
No
Principal Investigator
Wook Kim, Professor
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Surgery, Holy Family Hospital. The Catholic University of Korea
Authority:
Korea: Food and Drug Administration
Study ID:
HFHGS01
NCT ID:
NCT00741676
Start Date:
August 2008
Completion Date:
July 2013
Related Keywords:
- Stomach Neoplasm
- Neoplasms
- Stomach Neoplasms
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