Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer

Study Overview
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Brief Summary
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Among surgical methods for gastric cancer, incision about 15  20 cm length is prepared for open gastric cancer surgery while 0.5   1.2 cm is for laparoscopy gastric cancer surgery. Complications such as pain, abdominal adhesion, and problems associated with delayed recovery are common in open surgery because of large incision; however, those complications are less common in laparoscopy surgery because small sized incision is prepared. Range of surgery for curative dissection depends on the level of progress of a cancer, i.e., depends on whether gastric wall invasion, lymph node metastasis, or invasion to adjacent organs presented. Since recurrence in the lymph nodes after the operation is very common, the most important step in the gastric surgery is to dissect lymph node completely. According to the gastric cancer surgery manual published by Japan Gastric Cancer Association, more than D2 lymph node dissection is essential for improving survival rate in advanced gastric cancer. More than D2 lymph node dissection is relatively safely conducted by open surgery, whereas it is controversial in laparoscopy surgery because it is very hard to maintain surgical field under laparoscopic condition. Recently, widened rage of lymph node dissection by using laparoscopy is possible as laparoscopic surgical techniques are accumulated and new surgical devices are introduced. According to the case reports, D2 lymph node dissection by laparoscopy surgery shows similar results to the one by open surgery in aspects of recurrence rate and the number of dissected lymph node. Also, according to Hur and el., in case of upper gastric cancer, laparoscopy surgery is more useful to dissect #10 and #11 lymph node.In our prospective case study, the investigators would like to compare effectiveness, complications, patterns of recurrence, and survival rate between the two surgical approaches, laparoscopy distal gastrectomy and open distal gastrectomy. The investigators randomly operate the advanced gastric cancer patients, who need distal gastrectomy and D2 lymph node dissection. Surgical methods are selected randomly whether open surgery or laparoscopy surgery. Finally, the investigators wish our case report to contribute to the establishment of the safety and the effectiveness of laparoscopy surgery conducted for advanced gastric cancers. Consequently, our case report will contribute to establish the ideal surgical method for the advanced gastric cancer patients.

Detailed Description
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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.

Official Title
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Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).

Conditions
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Stomach Neoplasm

Intervention / Treatment
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* Procedure: laparoscopy-assisted distal gastrectomy
* Procedure: open distal gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br> | Procedure: open distal gastrectomy<br>* Approximately 15 20 cm length incision is made from falciform process to periumbilical area. 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, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.<br>* Other names: ODG;|
| Experimental: 1<br> | Procedure: laparoscopy-assisted distal gastrectomy<br>* 10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. 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, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.Dissected stomach and lymph node are collected through additional 3 5 cm incision at the preexisting epigastric incision.Finally, Billroth II reconstruction is performed.<br>* Other names: LADG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 year survival |  | two year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and clinical out come |  | two year |